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

Phase 2

Terminated

• Conditions: Dyslipidemia; Menopause; Obesity
• Interventions: Drug: Carduus marianus 6cH; Drug: Carduus marianus 12cH; Drug: Carduus marianus 30cH; Drug: Placebo; Behavioral: Exercise; Other: Diet

• Registration Number: NCT02775448
• Lead Sponsor: Hospital Nacional Homeopático, Mexico

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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-17
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

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

Exclusion Criteria

1. history of cardiovascular disease or coronary risk equivalents
2. secondary hyperlipidemia caused by diabetes mellitus, renal, liver or thyroid diseases
3. 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
4. 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
5. pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet + exercise + placebo	Diet	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.
Diet + exercise + Carduus marianus 6cH	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.
Diet + exercise + Carduus marianus 6cH	Exercise	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.
Diet + exercise + Carduus marianus 6cH	Diet	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.
Diet + exercise + Carduus marianus 12cH	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.
Diet + exercise + Carduus marianus 12cH	Exercise	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.
Diet + exercise + Carduus marianus 12cH	Diet	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.
Diet + exercise + Carduus marianus 30cH	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.
Diet + exercise + Carduus marianus 30cH	Exercise	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.
Diet + exercise + Carduus marianus 30cH	Diet	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.
Diet + exercise + placebo	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.
Diet + exercise + placebo	Exercise	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	8 weeks after randomization	Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.

Trial Locations

Locations (1)

Hospital Nacional Homeopático; 🇲🇽 Mexico City, Mexico