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ThymeLiv: The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Nonalcoholic Fatty Liver Disease

Sponsor
Shiraz University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02983669
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
4.2
Actual Duration (Months)
20.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effects and safety of a dietary supplement, Zataria multiflora Boiss (Shirazi's Thyme) in the treatment of non alcoholic fatty liver disease (NAFLD).

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

Detailed Description

In a randomized double-blind placebo-controlled clinical trial Shirazi's Thyme is compared with placebo. Investigators select randomly 90 patients with NAFLD by inclusion criteria. Investigators measure anthropometric and laboratory parameters including fasting blood sugar, insulin, liver enzymes, lipid profile, and grade in sonography before intervention and 90 days later. Patients are divided into two equal groups. Intervention group in addition to diet and exercise recommendations receive capsules containing 700 mg of Shirazi thyme powder daily for 90 days. Placebo group in addition to the same recommendations for diet and exercise, receives placebo capsules twice daily.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Zataria Multiflora Boiss (Shirazi's Thyme) on Biochemical Markers and Imaging Studies of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Apr 20, 2017
Actual Study Completion Date :
May 10, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thyme

Zataria multiflora Boiss powder capsule 350 mg twice daily for 3 months

Dietary Supplement: Thyme
Thyme capsule 350 mg twice daily
Other Names:
  • Shirazi's Thyme

    		•
    Placebo Comparator: Placebo

    Wheat powder capsule 350 mg twice daily for 3 months

    Other: Placebo
    Placebo capsule 350 mg twice daily

    Outcome Measures

    Primary Outcome Measures

    1. Change in ALT (Alanin aminotransferase) level [3 months]

    2. Change in grade of fatty liver in sonography by use of Saverymuttu Scoring System [3 months]

    Secondary Outcome Measures

    1. Change in AST (Aspartate aminotransferase) level [3 months]

    2. Fasting blood sugar (FBS) [3 months]

    3. Change in Gama GT (γ-glutamyl transpeptidase) level [3 monyhs]

    4. Fasting insulin level [3 months]

    5. Body weight [3 months]

    6. Waist circumference [3 months]

    7. Hip circumference [3 months]

    8. Number of patients with adverse events [4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age: 20-65 years

    • Body mass index: 18-35 kg/m2

    • Serum ALT level: >45 U/Lit. in Males, >29 U/Lit. in Females

    • Grade >=1 fatty liver in liver sonography

    Exclusion Criteria:

    • Pregnancy and Lactation

    • Acute or chronic liver failure

    • Acute or chronic renal failure

    • Autoimmune or viral hepatitis

    • Wilson's disease

    • Diabetes mellitus

    • Alcoholism

    • Malignancy

    • Hypothyroidism or hyperthyroidism

    • Drug used in last three months: OCP, metformin, vitamin E, ursodeoxycholic acid, glucocorticoids, thiazolidenediones.

    • History of allergic reactions to Thyme

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shahid Motahhari Clinic, Shiraz University of Medical Sciences Shiraz Fars Iran, Islamic Republic of

    Sponsors and Collaborators

    • Shiraz University of Medical Sciences

    Investigators

    • Principal Investigator: Majid Nimruzi, MD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
    • Principal Investigator: Mojtaba Heydari, MD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
    • Principal Investigator: Nasrin dokht Zamani, MD, Research Center for Traditional Medicine & History of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mesbah Shams, MD, Associate professor of Internal medicine and Endocrinology, Shiraz University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02983669
    Other Study ID Numbers:
    • 94-7648
    First Posted:
    Dec 6, 2016
    Last Update Posted:
    Oct 4, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Mesbah Shams, MD, Associate professor of Internal medicine and Endocrinology, Shiraz University of Medical Sciences
    Thymus Plant
    Multiflotriol [Supplementary Concept]
    Zataria multiflora
    Complementary Therapies
    Herbal Medicine
    Medicine, traditional
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Oct 4, 2017