A Study to Check the Safety and Benefits of Bonduc Nut Capsules for Women with Menopause Problems.

An Open-Label, Single-Arm, Single-Center Clinical Study To Evaluate The Safety And Efficacy of Bonduc Nut Capsules in Participants with Menopausal Symptoms - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100611

Enrollment

Registered

2026-01-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: N951- Menopausal and female climactericstates

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Perimenopausal women between 40 to 60 years of age with a history of menopausal symptoms for at least one month within the last one year. 2.Presence of moderate to severe menopausal symptoms like hot flashes night sweats insomnia nervousness mood swings vaginal dryness loss of libido. 3.Able and willing to give written informed consent and comply with the requirements.

Exclusion criteria

Exclusion criteria: 1.Participants with a history of psychiatric illness. 2.Participants who had surgical menopause. 3.Participants suffering from major systemic illness necessitating long term drug treatment like Rheumatoid arthritis Psycho-Neuro-Endocrinal disorders 4.Participants who are undergoing hormonal replacement therapy. 5.Participants having major organic pathology of the reproductive system like carcinoma fibroid cyst. 6.Participated in another clinical drug trial within 3 months before recruitment. 7.Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline. 8.Participants with any kind of malignancies.

Design outcomes

Primary

Measure	Time frame
1. Change in Menopausal Symptom Severity: -Change in total Menopausal Rating Scale (MRS) score from Baseline to Day 30. - Assesses improvement across somatic, psychological, and urogenital symptom domains (e.g., hot flashes, sleep disturbances, mood changes, vaginal dryness).Timepoint: Screening & Baseline(Day 0) Follow-up (Day 15 2 days) End of Study (Day 30 2 days)	—

Secondary

Measure	Time frame
1. Change in Global Symptom Perception: - Change in Patient Global Assessment (PGA) score from Baseline to Day 30. - Evaluates participant-reported overall improvement in menopausal symptoms.Timepoint: Screening & Baseline(Day 0) Follow-up (Day 15 2 days) End of Study (Day 30 2 days)	—

Countries

India

Contacts

Public ContactMs Mamatha B Gokavi

Samahitha Research Solutions

satyalm@samahitha.com9739001749

Outcome results