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

Hospital Nacional Homeopático, Mexico

Status and phase: Terminated; Phase 2

Conditions: Menopause; Obesity; Dyslipidemia

Treatments: Other: Diet; Drug: Carduus marianus 6cH; Drug: Placebo; Drug: Carduus marianus 30cH; Behavioral: Exercise; Drug: Carduus marianus 12cH

Study type: Interventional

Funder types: Other

Identifiers

NCT02775448

HospitalNHMexico

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 4 patient groups, including a placebo group

Diet + exercise + Carduus marianus 6cH

Experimental group

Description:

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.

Treatment:

Other: Diet

Behavioral: Exercise

Drug: Carduus marianus 6cH

Diet + exercise + Carduus marianus 12cH

Experimental group

Description:

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.

Treatment:

Other: Diet

Drug: Carduus marianus 12cH

Behavioral: Exercise

Diet + exercise + Carduus marianus 30cH

Experimental group

Description:

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.

Treatment:

Drug: Carduus marianus 30cH

Other: Diet

Behavioral: Exercise

Diet + exercise + placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Diet

Drug: Placebo

Behavioral: Exercise