Prevention and management of neuropsychiatric and cardiovascular complications by an Ayurvedic formulation among menopausal wome
Phase 3
- Conditions
- Health Condition 1: null- Menopausal syndrome
- Registration Number
- CTRI/2015/01/005365
- Lead Sponsor
- SRM University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
1. Complaining menopausal symptoms
2. Serum FSH >30 mIU/ml
3. Serum estradiol <35pg/ml
Exclusion Criteria
1. Hypothyroidism
2. History of chronic fatigue syndrome
3. Any gross cardiovascular involvement
4. Severe depression
5. Lipid profile ? Total cholesterol > 300mg/dl
6. LDL-c >160mg/dl
7. Triglyceride > 450mg/dl
8. Fasting blood glucose > 150mg/dl
9. Postprandial blood glucose > 300mg/dl
10. Pulse rate above 100 p.m.
11. Any major illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The menopausal women showed improvement in clinical complaints particularly the vasomotor instability and depression. Further, the coronary risk factors like dyslipidemia, obesity, elevated inflammatory markers and endothelial dysfunction modified significantly indicating the prevention from development of CHD among menopausal women. Initially, the trial will be continued upto 3 years and subsequently extended upto 5 years subject to improvement in clinical conditions.Timepoint: Gradual improvement 1 to 6 months treatment
- Secondary Outcome Measures
Name Time Method Improvement in overall feeling of well being, improved work performance, better sleep, anxiety and depression including improvement in early fatigability was noticed in menopausal women treated with test formulation. Initially, the trial will be continued upto 3 years and subsequently extended upto 5 years subject to improvement in clinical conditions.Timepoint: Gradual improvement 1 to 6 months treatment