Prevention and management of neuropsychiatric and cardiovascular complications by an Ayurvedic formulation among menopausal women

A randomized double blind placebo controlled clinical trial on an Ayurvedic medicine beneficial in the management of neuropsychiatric and cardiovascular complications among menopausal women

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/01/005365

Enrollment

1000

Registered

2015-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Menopausal syndrome

Interventions

Intervention1: Test formulation 500mg twice per day for a period of six months: The novel test formulation was prepared from Shade dried bulbs of Dioscorea bulbifera, bark of Terminalia rjuna, leaves

Eligibility

Inclusion criteria

Inclusion criteria: 1. Complaining menopausal symptoms 2. Serum FSH >30 mIU/ml 3. Serum estradiol <35pg/ml

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactDr R Mohankumar

Interdisciplinary School oaf Indian System of Medicine

gpdubey13@gmail.com9450963942

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026