Clinical trial NCT02775448: Dose-response Study of Carduus Marianus in Centesimal Scale for Dyslipidemia in Climacteric Overweighed or Obese Women.
Official title: Dose-response Study of the Efficacy and Safety of Carduus Marianus in Centesimal Scale for Dyslipidemia in Overweighed or Obese Women in Peri- and Postmenopause: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyslipidemia
Menopause
Obesity
Keywords: Homeopathy
Carduus marianus
Dyslipidemia
Climacteric
Obesity
Triglycerides
Cholesterol
Insulin resistance
LDL-cholesterol
HDL-cholesterol
Lead sponsor: Hospital Nacional Homeopático, Mexico
Sponsor class: OTHER
Collaborators: name: Laboratorio Similia, México
First posted: 2016-05-17
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline level of triglycerides at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline level of total cholesterol at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
Secondary outcomes:
measure: Change from baseline level of LDL cholesterol at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline level of HDL cholesterol at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline level of fasting glucose at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline level of glycosylated hemoglobin at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline [HOMA-IR=insulin(mU/ml) X glucose (mg/dl)/405] at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline weight (kg) at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline body mass index (Kg/m2) at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Change from baseline waist circumference (cm) at 4 and 8 weeks.
timeFrame: 4 and 8 weeks after randomization
measure: Adverse events
timeFrame: 4 weeks after randomization
measure: Adverse events
timeFrame: 8 weeks after randomization
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Nacional Homeopático
Study officials:
affiliation: Hospital Nacional Homeopático
name: Emma del Carmen Macias-Cortes, PhD
role: PRINCIPAL_INVESTIGATOR
References: