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Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion

Sponsor
University of Guadalajara (Other)
Overall Status
Completed
CT.gov ID
NCT02330341
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The term prediabetes has been used to encompass the first alterations on glucose metabolism such as impaired fasting glucose and glucose intolerance, and its early detection and treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease worldwide.

Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the treatment of diabetes.

Different in vitro and in vivo studies have shown that Artemisia dracunculus increases insulin signaling and improves insulin sensitivity.

The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance, insulin sensitivity and insulin secretion.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Artemisia dracunculus
  • Other: Placebo
 N/A

Detailed Description

A randomized, double-blind, placebo-controlled clinical trial will be carried out in 24 patients with diagnosis of glucose intolerance in accordance with the criteria of American Diabetes Association (ADA). Glucose, insulin levels, lipid profile, creatinine, uric acid, and transaminases will be evaluated. An oral glucose tolerance test with 75 g of dextrose will be held.

12 participants will receive Artemisia dracunculus, 1000 mg, twice per day (2000 mg) before breakfast and dinner during 3 months. And other 12 patients will receive placebo with the same prescription.

Area Under de Curve of glucose and insulin will be calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol is approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Results will be presented as mean and standard deviation. Intra an inter group differences will be tested using the Wilcoxon signed-ran and Mann Whitney U- test respectively; p<0.05 will be considered significant.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a study with two groups of patients with prediabetes. One group received the investigational product (Artemisia Dracunculus) and the other received placebo as control.This is a study with two groups of patients with prediabetes. One group received the investigational product (Artemisia Dracunculus) and the other received placebo as control.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
Actual Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Artemisia Dracunculus

Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days

Dietary Supplement: Artemisia dracunculus
Other Names:
  • estragon, tarragon

    		•
    Placebo Comparator: Placebo

    Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days

    Other: Placebo
    Other Names:
  • calcined magnesia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postprandial Glucose Levels at Week 12 [Week 12]

      Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques

    2. Fasting Glucose Levels at Week 12 [Week 12]

      Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

    3. Glycosylated Hemoglobin at Week 12 [Week 12]

      Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA

    4. First Phase of Insulin Secretion at Week 12 [Week 12]

      The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion

    5. Total Insulin Secretion at Week 12 [Week 12]

      Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion

    6. Insulin Sensitivity at Week 12 [Week 12]

      Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity

    Secondary Outcome Measures

    1. Weight at Week 12 [Week 12]

      The weight will be measured at baseline and week 12 with a bioimpedance balance

    2. Body Mass Index at Week 12 [Week 12]

      Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula

    3. Total Cholesterol at Week 12 [Week 12]

      Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques

    4. Triglycerides Levels at Week 12 [Week 12]

      Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

    5. High Density Lipoprotein (c-HDL) Levels at Week 12 [Week 12]

      c-HDL levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

    6. Alanine Aminotransferase (ALT) Levels at Week 12 [Week 12]

      ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

    7. Aspartate Aminotransferase (AST) Levels at Week 12 [Week 12]

      AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

    8. Creatinine Levels at Week 12 [Week 12]

      Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

    9. Uric Acid Levels at Week 12 [Week 12]

      Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques

    10. Systolic Blood Pressure at Week 12 [Week 12]

      Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer

    11. Diastolic Blood Pressure at Week 12. [Week 12]

      Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients both sexes

    • Age between 30 and 60 years

    • Glucose intolerance according ADA criteria (blood glucose leve ≥140 mg/dl and ≤199 mg/dL after an oral glucose tolerance test with 75 of oral glucose

    • Informed consent signed

    Exclusion Criteria:

    • Women with confirmed or suspected pregnancy

    • Women under lactation and/or puerperium

    • Hypersensibility to Artemisia dracunculus

    • Physical impossibility for taking pills

    • Known uncontrolled renal, hepatic, heart or thyroid disease

    • Previous treatment for glucose

    • Diabetes diagnosis

    • BMI ≥39.9 kg/m2

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Manuel González Ortiz Guadalajara Jalisco Mexico 44140

    Sponsors and Collaborators

    • University of Guadalajara

    Investigators

    • Principal Investigator: MANUEL GONZALEZ, PhD, University of Guadalajara

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manuel González Ortiz, Researcher Professor, University of Guadalajara
    ClinicalTrials.gov Identifier:
    NCT02330341
    Other Study ID Numbers:
    • GI-ESTRAGON
    First Posted:
    Jan 1, 2015
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Manuel González Ortiz, Researcher Professor, University of Guadalajara
    Glucose Intolerance
    Artemisia dracunculus
    Insulin
    Additional relevant MeSH terms:
    Insulin Resistance
    Glucose Intolerance

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Period Title: Overall Study
    STARTED 12 12
    COMPLETED 12 11
    NOT COMPLETED 0 1

    Baseline Characteristics

    Arm/Group Title Artemisia Dracunculus Placebo Total
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo Total of all reporting groups
    Overall Participants 12 12 24
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48.1
    (7)
    48.5
    (7.2)
    48.3
    (6.9)
    Sex: Female, Male (Count of Participants)
    Female
    9
    75%
    11
    91.7%
    20
    83.3%
    Male
    3
    25%
    1
    8.3%
    4
    16.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    12
    100%
    12
    100%
    24
    100%
    Not Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Mexico
    12
    100%
    12
    100%
    24
    100%
    Postprandial glucose levels (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    10
    (1.3)
    9.7
    (1.1)
    9.9
    (1.2)
    Fasting glucose levels (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    5.5
    (0.8)
    5.9
    (0.9)
    5.7
    (0.8)
    Glycosylated Hemoglobin (percentage) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [percentage]
    5.8
    (0.3)
    5.9
    (0.4)
    5.8
    (0.4)
    First phase of insulin secretion (index) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [index]
    1057
    (529)
    1395
    (1138)
    1226
    (885)
    Total insulin secretion (index) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [index]
    0.5
    (0.2)
    0.7
    (0.4)
    0.6
    (0.3)
    Insulin sensitivity (index) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [index]
    2.6
    (1.3)
    1.9
    (1.2)
    2.3
    (1.3)
    Weight (kilograms) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms]
    85.3
    (7.7)
    83
    (10.2)
    84.1
    (8.9)
    Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    33.1
    (2.9)
    34.1
    (3.2)
    33.6
    (3.0)
    Total Cholesterol (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    5.6
    (1)
    5
    (0.8)
    5.3
    (1)
    Triglycerides (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    2.5
    (1.5)
    1.7
    (0.8)
    2.2
    (1.3)
    High Density Lipoprotein (HDL-c) (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    1.3
    (0.3)
    1.4
    (0.4)
    1.3
    (0.3)
    Alanine Aminotransferase (ALT) (U/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [U/L]
    43.8
    (25.2)
    28.8
    (14.1)
    36.3
    (21.4)
    Aspartate Aminotransferase (AST) (U/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [U/L]
    32.2
    (17.7)
    26.4
    (7.8)
    29.3
    (11.3)
    Creatinine (umol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [umol/L]
    63.7
    (8.8)
    65.4
    (17.7)
    64.6
    (11.5)
    Uric Acid (umol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [umol/L]
    285.5
    (113)
    273.6
    (58.9)
    279.6
    (132.6)
    Systolic blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    120
    (11)
    123
    (10)
    121.6
    (10.8)
    Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmHg]
    78
    (7)
    75
    (7)
    76.4
    (7.5)

    Outcome Measures

    1. Primary Outcome
    Title Postprandial Glucose Levels at Week 12
    Description Postprandial glucose will be evaluated at baseline and week 12 after a oral glucose tolerance test with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [mmol/L]
    9.5
    (1.8)
    9.9
    (2.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.380
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of postprandial glucose on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.695
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments The threshold for statistical significance was p=0.05
    2. Primary Outcome
    Title Fasting Glucose Levels at Week 12
    Description Fasting glucose will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [mmol/L]
    5.9
    (0.6)
    5.9
    (0.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of fasting glucose on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.110
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of fasting glucose on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.910
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    3. Primary Outcome
    Title Glycosylated Hemoglobin at Week 12
    Description Glycosylated hemoglobin will be evaluated at baseline and week 12 by ELISA
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [percentage]
    5.6
    (0.4)
    5.8
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.010
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of glucosylated hemoglobin on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.938
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    4. Primary Outcome
    Title First Phase of Insulin Secretion at Week 12
    Description The first phase of insulin secretion will be calculated at baseline and week 12 with Stumvoll index. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [index]
    1235
    (1047)
    1566
    (1206)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.733
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of first phase of insulin secretion on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.0
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    5. Primary Outcome
    Title Total Insulin Secretion at Week 12
    Description Total insulin secretion will be calculated at baseline and week 12 with insulinogenic index. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [index]
    0.35
    (0.2)
    0.75
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.03
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of total insulin secretion on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.900
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    6. Primary Outcome
    Title Insulin Sensitivity at Week 12
    Description Insulin sensitivity will be calculated at baseline and week 12 with Matsuda index. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [index]
    2.4
    (1.0)
    1.8
    (0.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.519
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of insulin sensitivity on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.922
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    7. Secondary Outcome
    Title Weight at Week 12
    Description The weight will be measured at baseline and week 12 with a bioimpedance balance
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [kilograms]
    85.3
    (8.2)
    84.0
    (11.0)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of weight on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.605
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of weight on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.105
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    8. Secondary Outcome
    Title Body Mass Index at Week 12
    Description Body Mass Index will be calculated at baseline and week 12 with the Quetelet index formula
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [kg/m^2]
    33.2
    (2.9)
    34.4
    (3.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of BMI on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.687
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of BMI on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.021
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    9. Secondary Outcome
    Title Total Cholesterol at Week 12
    Description Total cholesterol levels will be evaluated at baseline and week 12 by enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [mmol/L]
    5.4
    (1.2)
    5.0
    (0.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of total cholesterol on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.339
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of total cholesterol on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.246
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    10. Secondary Outcome
    Title Triglycerides Levels at Week 12
    Description Triglycerides levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [mmol/L]
    2.2
    (0.7)
    1.8
    (0.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of triglycerides on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.775
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of triglycerides on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.195
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    11. Secondary Outcome
    Title High Density Lipoprotein (c-HDL) Levels at Week 12
    Description c-HDL levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [mmol/L]
    1.4
    (0.3)
    1.3
    (0.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of HDL-c on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.040
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of HDL-c on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1.000
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    12. Secondary Outcome
    Title Alanine Aminotransferase (ALT) Levels at Week 12
    Description ALT levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [U/L]
    32.8
    (17.7)
    36.7
    (18.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of ALT on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.021
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of ALT on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.080
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    13. Secondary Outcome
    Title Aspartate Aminotransferase (AST) Levels at Week 12
    Description AST levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [U/L]
    30.3
    (18.1)
    26.7
    (9.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of AST on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.465
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of AST on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.574
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    14. Secondary Outcome
    Title Creatinine Levels at Week 12
    Description Creatinine levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [umol/L]
    61.01
    (16.8)
    61.01
    (13.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of creatinine on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.480
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of creatinine on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.383
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    15. Secondary Outcome
    Title Uric Acid Levels at Week 12
    Description Uric acid levels will be evaluated at baseline and week 12 with enzymatic-colorimetric techniques
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [umol/L]
    350.9
    (71.4)
    309.3
    (50.6)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of uric acid on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of uric acid on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.080
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    16. Secondary Outcome
    Title Systolic Blood Pressure at Week 12
    Description Systolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [mmHg]
    113
    (11)
    125
    (8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.017
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of systolic blood pressure on placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.082
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    17. Secondary Outcome
    Title Diastolic Blood Pressure at Week 12.
    Description Diastolic blood pressure will be measured at baseline and week 12 with a digital sphygmomanometer
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    Measure Participants 12 11
    Mean (Standard Deviation) [mmHg]
    75
    (8)
    79
    (9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Artemisia Dracunculus
    Comments Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure on Artemisia Dracunculus group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.170
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo
    Comments Results showed in this section are the result of the differences between baseline and final values of diastolic blood pressure placebo group
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.199
    Comments The threshold for statistical significance was p=0.05
    Method Wilcoxon (Mann-Whitney)
    Comments

    Adverse Events

    Time Frame Adverse events were collected during the 12 weeks of the study.
    Adverse Event Reporting Description
    Arm/Group Title Artemisia Dracunculus Placebo
    Arm/Group Description Artemisia Dracunculus extract, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Artemisia dracunculus Calcined magnesia, 2 capsules of 500 mg, two times per day before breakfast and dinner during 90 days Placebo
    All Cause Mortality
    Artemisia Dracunculus Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/12 (0%)
    Serious Adverse Events
    Artemisia Dracunculus Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Artemisia Dracunculus Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/12 (8.3%) 2/12 (16.7%)
    Gastrointestinal disorders
    Constipation 1/12 (8.3%) 1 2/12 (16.7%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title DR. MANUEL GONZALEZ ORTIZ
    Organization INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA
    Phone +52 3310585200 ext 34212
    Email uiec@prodigy.net.mx
    Responsible Party:
    Manuel González Ortiz, Researcher Professor, University of Guadalajara
    ClinicalTrials.gov Identifier:
    NCT02330341
    Other Study ID Numbers:
    • GI-ESTRAGON
    First Posted:
    Jan 1, 2015
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Sep 1, 2020