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A Study to assess the effect of Unani Formulation versus placebo on Vaginal laxity

Efficacy of Unani Formulation in the management of ISTERQA-E-MEHBAL(VAGINAL LAXITY)-A Single blinded randomised placebo-controlled clinical trial - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086292
Enrollment
64
Registered
2025-05-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: N899- Noninflammatory disorder of vagina, unspecified

Interventions

Intervention1: Group A:UNANI COMPOUND FORMULATION: Patients of Group A will be given each 3.5gm Firzaja (Pessary) will contain the UNANI COMPOUND FORMULATION with the following ingredients 1.Maayin Kh
3.5gm Firzaja (Pessary)will be inserted per Vaginal and removed after 5 hours every day for Seven consecutive days after menses. The procedure will be continued for Three consecutive months. Control
3.5gm Firzaja (Pessary)will be inserted per Vaginal and removed after 5 hours every day for Seven consecutive days after menses. The procedure will be continued for Three consecutive months.

Sponsors

Government Nizamia Tibbi College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age ranging from 20-45years. 2.Non-pregnant. 3.With at least one parity. 4.Presenting signs and symptoms of Vaginal laxity.

Exclusion criteria

Exclusion criteria: 1.Age below 20 or above 45 Years. 2.Pregnant women. 3.Have attained Menopause. 4.Other systemic disorders. 5.With history of urogenital infections. 6.Have experienced recent stressful events in their life. 7.Smokers. 8.With Sexually Transmitted Diseases. 9.With history of urogynecological surgeries, symptomatic genital prolapses. 10.Have suffered with chronic diseases.

Design outcomes

Primary

MeasureTime frame
Enhanced vaginal tightnessTimepoint: 0th day,30th day,60th day,90th day

Secondary

MeasureTime frame
Improved sexual functionTimepoint: 0th day, 90th day

Countries

India

Contacts

Public ContactDr Khursheed Fatima

Government Nizamia Tibbi College and General Hospital

drssntc@gmail.com9908624090

Outcome results

None listed

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