Dose-response Study of Carduus Marianus in Centesimal Scale for Dyslipidemia in Climacteric Overweighed or Obese Women.

Sponsor

Hospital Nacional Homeopático, Mexico (Other)

Overall Status

Terminated

CT.gov ID

NCT02775448

Collaborator

Laboratorio Similia, México (Other)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Metabolic disorders including hypercholesterolemia and hypertriglyceridemia are present in climacteric women. Carduus marianus is a homeopathic medicine that traditionally has been used for hepatic diseases. It has been used for reducing hypercholesterolemia and hypertriglyceridemia also. The aim of this study is to investigate the most effective dose of Carduus marianus in centesimal scale (6cH, 12cH, 30cH, placebo) plus diet and exercise for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia Menopause Obesity	Drug: Carduus marianus 6cH Drug: Carduus marianus 12cH Drug: Carduus marianus 30cH Drug: Placebo Behavioral: Exercise Other: Diet	Phase 2

Detailed Description

The prevalence of metabolic disorders including dyslipidemia increases as women transition from premenopause to postmenopause. This increases the risk for morbidity and mortality from cardiovascular diseases. Carduus marianus is a homeopathic medicine that traditionally has been used for hepatic diseases. Silymarin, isolated from Carduus marianus, owe its therapeutic and hepatoprotective effects to its strong antioxidant and anti-inflammatory properties. Carduus marianus is frequently used in clinical practice and reduces plasma level of triglycerides, total cholesterol and LDL in humans with dyslipidemia. Not all homeopaths agree on dosage and potency when prescribing homeopathic medicines. The aim of this study is to assess: (1) the most effective dose of Carduus marianus in centesimal scale for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women; (2) the effect of Carduus marianus in other metabolic parameters (glucose, glycosylated hemoglobin, insulin resistance, weight, body mass index, waist circumference).

This is a 8-week, double-blind, randomized, parallel, four-group, dose-response study to assess the safety and efficacy of Carduus marianus in 6cH, 12cH, 30cH and placebo plus diet and exercise, for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Dose-response Study of the Efficacy and Safety of Carduus Marianus in Centesimal Scale for Dyslipidemia in Overweighed or Obese Women in Peri- and Postmenopause: a Randomized Controlled Trial

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diet + exercise + Carduus marianus 6cH Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 6cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.	Drug: Carduus marianus 6cH Behavioral: Exercise aerobic exercise, 30 minutes, daily Other: Diet 1600 calories
Experimental: Diet + exercise + Carduus marianus 12cH Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 12cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.	Drug: Carduus marianus 12cH Behavioral: Exercise aerobic exercise, 30 minutes, daily Other: Diet 1600 calories
Experimental: Diet + exercise + Carduus marianus 30cH Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 30c, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.	Drug: Carduus marianus 30cH Behavioral: Exercise aerobic exercise, 30 minutes, daily Other: Diet 1600 calories
Placebo Comparator: Diet + exercise + placebo Diet (1600 cal/day) + aerobic exercise (30 min daily) + placebo (87°alcohol), 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.	Drug: Placebo Behavioral: Exercise aerobic exercise, 30 minutes, daily Other: Diet 1600 calories

Outcome Measures

Primary Outcome Measures

Change from baseline level of triglycerides at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline level of total cholesterol at 4 and 8 weeks. [4 and 8 weeks after randomization]

Secondary Outcome Measures

Change from baseline level of LDL cholesterol at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline level of HDL cholesterol at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline level of fasting glucose at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline level of glycosylated hemoglobin at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline [HOMA-IR=insulin(mU/ml) X glucose (mg/dl)/405] at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline weight (kg) at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline body mass index (Kg/m2) at 4 and 8 weeks. [4 and 8 weeks after randomization]
Change from baseline waist circumference (cm) at 4 and 8 weeks. [4 and 8 weeks after randomization]
Adverse events [4 weeks after randomization]
Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.
Adverse events [8 weeks after randomization]
Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women 40-65 years in early or late transition to menopause or postmenopause according to STRAW classification
hypertriglyceridemia [>150 <1000 mg/dL], and/or hypercholesterolemia [>200mg/dL]
overweight or obesity [BMI >25 Kg/m2]
fasting glucose <126mg/dL
glycosylated hemoglobin <6.5%
be willing and capable to follow study procedures.

Exclusion Criteria:

history of cardiovascular disease or coronary risk equivalents
secondary hyperlipidemia caused by diabetes mellitus, renal, liver or thyroid diseases
hypolipidemic agents, antidiabetic medication, hormone replacement therapy, tamoxifen, raloxifene, danazol, isotretinoin, acitretin, cyclosporin, azathioprine, protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), antipsychotics (clozapine), seizure medication (carbamazepine, valproic acid, phenobarbital, phenytoin) either on-going or any time in the previous 2 months
any other clinically significant illness that, in the opinion of the investigator, might put the patient at risk of harm during the study or might adversely affect the interpretation of the study data
pregnancy or breastfeeding.