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

• Status: Terminated
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Nacional Homeopático, Mexico
• Collaborator: Laboratorio Similia, México

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.