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Effect of Unani formulation versus metronidazole in leucorrhoea due to bacterial vaginosis- A randomized controlled trial

Effect of vaginal application of Unani formulation versus metronidazole in leucorrhoea due to bacterial vaginosis- A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080007
Enrollment
54
Registered
2025-02-06
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

Health Condition 1: N888- Other specified noninflammatory disorders of cervix uteri

Interventions

Intervention1: Unani formulation (Mazu Rasaut Kundur Samaq and Shibb-i-yamani : hamul (5g) will be prepared & prescribed for per vaginal use once daily at bed time for 14 days. Intervention2: Unani

Sponsors

National Institute of Unani Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Married women in age group of 18-45 years presenting with complain of offensive vaginal discharge, pruritus vulvae, pelvic pain. Study participants with Positive Amsels criteria (more than equal to 3 out of 4) and Nugent score (b/w 4-7 with p/o clue cells and more than equal to 7 irrespective of clue cells).

Exclusion criteria

Exclusion criteria: Uncontrolled systemic diseases (DM, HTN, TD), malignancy, pelvic pathology(21) Trichomoniasis and candidiasis (excluded based on microscopy and characteristic of discharge)(6,15) Gonorrhoea and other types of vaginitis(16,20,21) OCPs and IUCD(20) Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Improvement in Nugent scoreTimepoint: baseline,14th day

Secondary

MeasureTime frame
Improvement in Amsels criteriaTimepoint: baseline & 14th day

Countries

India

Contacts

Public ContactProf Ismath Shameem

National Institute of Unani Medicine

dr.ismaths@gmail.com9449977008

Outcome results

None listed

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