Dyslipidemia, Menopause, Obesity
Conditions
Keywords
Homeopathy, Carduus marianus, Dyslipidemia, Climacteric, Obesity, Triglycerides, Cholesterol, Insulin resistance, LDL-cholesterol, HDL-cholesterol
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.
Interventions
DRUGCarduus marianus 6cH
DRUGCarduus marianus 12cH
DRUGCarduus marianus 30cH
DRUGPlacebo
BEHAVIORALExercise
aerobic exercise, 30 minutes, daily
OTHERDiet
1600 calories
Sponsors
Laboratorio Similia, México
Hospital Nacional Homeopático, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 level of LDL cholesterol 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. |
| Change from baseline weight (kg) 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 | — |
Countries
Mexico
Outcome results
None listed