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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dyslipidemia Menopause Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Carduus marianus 6cH

Intervention Type DRUG

Exercise

Intervention Type BEHAVIORAL

aerobic exercise, 30 minutes, daily

Diet

Intervention Type OTHER

1600 calories

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.

Group Type EXPERIMENTAL

Carduus marianus 12cH

Intervention Type DRUG

Exercise

Intervention Type BEHAVIORAL

aerobic exercise, 30 minutes, daily

Diet

Intervention Type OTHER

1600 calories

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.

Group Type EXPERIMENTAL

Carduus marianus 30cH

Intervention Type DRUG

Exercise

Intervention Type BEHAVIORAL

aerobic exercise, 30 minutes, daily

Diet

Intervention Type OTHER

1600 calories

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Exercise

Intervention Type BEHAVIORAL

aerobic exercise, 30 minutes, daily

Diet

Intervention Type OTHER

1600 calories

Interventions

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Carduus marianus 6cH

Intervention Type DRUG

Carduus marianus 12cH

Intervention Type DRUG

Carduus marianus 30cH

Intervention Type DRUG

Placebo

Intervention Type DRUG

Exercise

aerobic exercise, 30 minutes, daily

Intervention Type BEHAVIORAL

Diet

1600 calories

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No