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To study the effect of black cohosh in post-menopausal women by reducing menopausal symptoms

Effectiveness of Black Cohosh on Menopausal Symptoms in Post-Menopausal Women- A Block Randomised Double Blind Placebo Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080583
Enrollment
114
Registered
2025-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

None listed

Interventions

Intervention1: BLACK COHOSH: Dose:40mg capsule Frequency:(0-0-1) Administration: after food Duration:3months Control Intervention1: Placebo: Dose:40mg capsule Frequency: (0-0-1) Administration: after

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.women with age 45-60 years 2.Amenorrhea more that 12 months 3.BMI less than equal to 35 kg/m2 4.presence of two or more menopausal symptoms 5.severity ranges from mild to moderate 6.participants willing to provide written informed consent and carry out studied procedures

Exclusion criteria

Exclusion criteria: 1.Abnormal vaginal bleeding 2.Severe blood pressure more than 190/120mmhg 3.Severe diabetes (Hba1c more than 10) 4.BMI more than equal to 35kg/m2 5.History of breast cancer and uterine cancer 6.Thromboembolic or Thrombophilia taking hormone or anti-peri menopausal medication 7.Liver disease 8.Thyroid Disorder 9.Depression 10.Use of steroids or any herbal medications for treatment of menopausal symptoms 11.Psychiatric drugs within last 2 months of treatment 12.Smoking and alcohol consumptions 13.Drug abuse 14.Subjects participated in any study before 180 days 15.Subjects using hormonal replacement therapy, non-hormonal replacement therapy, sedatives, antidepressants, anti-epileptic and subjects receiving alternative system of medicines 16.Patient unwilling to sign the informed consent

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of Black Cohosh in improving the menopausal symptoms in post menopausal women through menopausal rating scale in comparison with placeboTimepoint: 1 year—

Secondary

MeasureTime frame
To assess the effectiveness of Black Cohosh in improving the quality of life in post menopausal women To assess the safety and adverse drug reaction (ADR) of Black Cohosh if any through World Health Organization - Uppsala Monitoring Centre (WHO-UMC) causality assessment scaleTimepoint: 1 year—

Countries

India

Contacts

Public ContactDr M G Rajanandh

SRM Medical college hospital and research center

melving@srmist.edu.in9080281508

Outcome results

None listed

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