| CTRI Number |
CTRI/2025/08/093463 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to evaluate the effect of Unani Topical Medicine on Early Cervical Cell Changes in Women |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syeda Hajra Fatima |
| Designation |
Research Officer Pathology Scientist level II |
| Affiliation |
National Research Institute of Unani medicine for Skin Disorders |
| Address |
Department of Pathology, National Research Institute of Unani medicine for Skin Disorders, Erragadda, Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
7981875992 |
| Fax |
|
| Email |
dr.syeda.hajra04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syeda Hajra Fatima |
| Designation |
Research Officer Pathology Scientist level II |
| Affiliation |
National Research Institute of Unani medicine for Skin Disorders |
| Address |
Department of Pathology, National Research Institute of Unani medicine for Skin Disorders, Erragadda, Hyderabad.
TELANGANA
500038
India |
| Phone |
7981875992 |
| Fax |
|
| Email |
dr.syeda.hajra04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syeda Hajra Fatima |
| Designation |
Research Officer Pathology Scientist level II |
| Affiliation |
National Research Institute of Unani medicine for Skin Disorders |
| Address |
Department of Pathology, National Research Institute of Unani medicine for Skin Disorders, Erragadda, Hyderabad.
TELANGANA
500038
India |
| Phone |
7981875992 |
| Fax |
|
| Email |
dr.syeda.hajra04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine,Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No. 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058, India. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No. 61-65, Institutional Area,
Opp. D-Block, Janakpuri,
New Delhi - 110058 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr syeda hajra fatima |
National Research Institute of Unani medicine for Skin Disorders |
AG COLONY ROAD,Erragadda, National Research Institute of Unani medicine for Skin Disorders, Hyderabad, 500038, Telangana, India.
Hyderabad
TELANGANA |
7981875992
dr.syeda.hajra04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N870||Mild cervical dysplasia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 bedtime for eight weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 –LSIL |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
8 weeks
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Women with Low-Grade Squamous Intraepithelial
Lesion (LSIL) on Pap smear have a risk of progression to High-Grade Squamous
Intraepithelial Lesion (HSIL). Studies report that about 13% of untreated LSIL
cases progress to HSIL within 2 years, so close monitoring is essential to
prevent cervical carcinoma. In modern medicine, LSIL may be managed by observation, cryotherapy, excision treatment.
The Unani system of medicine includes many formulations with anticancer,
antioxidant, anti-inflammatory, and wound-healing activities, though clinical
studies are limited. Marham-e-Dakhilyun is one such formulation, known for its
anti-inflammatory, desiccant, wound-healing, astringent, and antiseptic properties.
This clinical study aims to evaluate the efficacy and safety of topical
Marham-e-Dakhilyun ointment in women with cervical dysplasia (LSIL). The
expected outcome is resolution of cytological changes seen in Pap smear and
prevention of progression to cervical cancer. |