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Study to evaluate the effect of Unani Topical Medicine on Early Cervical Cell Changes in Women

A single-arm pilot clinical study to evaluate the safety and efficacy of a Topical Unani formulation in the management of Cervical Low-Grade Squamous Intraepithelial Lesion (LSIL) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093463
Enrollment
30
Registered
2025-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: N870- Mild cervical dysplasia

Interventions

Intervention1: Marham-e-Dakhilyun: The Marham-e-Dakhilyun Ointment will be administered to the patients with the help of vaginal cream pessary per vagina in dosage of 6 g of ointment daily once at be

Sponsors

Central Council for Research in Unani Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Married women Aged 20 to 60 years 2.Patients with clinical signs and symptoms of Cervical Dysplasia including vaginal white discharge, backache, irregular vaginal spotting or postcoital bleeding 3.Confirmed cases of LSIL in Pap smears 4.Willingness to participate in the study and follow the schedule

Exclusion criteria

Exclusion criteria: 1.Unmarried women 2.Women aged less than 20 and more than 60 years 3.High grade abnormal lesions in Pap smears, HSIL, ASC-H, AGC 4.Associated gynecological pathology like Pelvic inflammatory disease, ovarian tumor, prolapse, polyp. 5.Known cases of systemic disease like Diabetes mellitus, hepatorenal, cardiac , pulmonary disorder Immuno-compromised states (HIV/ AIDS) 6.Pregnant and lactating mother 7.Subjects those who are unwilling to come regular follow ups for the entire duration of study

Design outcomes

Primary

MeasureTime frame
Topical application of the unani formulation is expected to resolve the cytological changes observe in the Pap smear in patients Low-Grade Squamous Intraepithelial Lesion ?LSILTimepoint: 8 weeks

Secondary

MeasureTime frame
1. To assess the safety and tolerability of topical Unani formulation in patients with Low-Grade Squamous Intraepithelial Lesion (LSIL). 2. To evaluate the potential therapeutic activity of topical Unani formulation in women with LSIL.Timepoint: 8 weeks

Countries

India

Contacts

Public ContactDr Syeda Hajra Fatima

National Research Institute of Unani medicine for Skin Disorders

dr.syeda.hajra04@gmail.com7981875992

Outcome results

None listed

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