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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Hospital Nacional Homeopático
Mexico City, Mexico
Change from baseline level of triglycerides at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline level of total cholesterol at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline level of LDL cholesterol at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline level of HDL cholesterol at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline level of fasting glucose at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline level of glycosylated hemoglobin at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline [HOMA-IR=insulin(mU/ml) X glucose (mg/dl)/405] at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline weight (kg) at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline body mass index (Kg/m2) at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Change from baseline waist circumference (cm) at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Adverse events
Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.
Time frame: 4 weeks after randomization
Adverse events
Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.
Time frame: 8 weeks after randomization
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