| CTRI Number |
CTRI/2025/07/089980 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to see the effect of sitz bath in the decoction of myrtle berries in patients of cervical erosion |
|
Scientific Title of Study
|
Therapeutic evaluation of abzan of habb-ul-aas (Myrtus communis Linn.) in cervical erosion An Open Interventional Trial |
| 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 Farheen Fatima |
| Designation |
PG scholar |
| Affiliation |
State takmeel ut tib college and hospital |
| Address |
Department of niswan wa qabalat state takmeel ut tib college and hospital near ramabai rally sthal
Near ramabai rally sthal aurangabad
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
918318902295 |
| Fax |
|
| Email |
fatimafarheen692@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mariyam Roqaiya |
| Designation |
Assistant professor |
| Affiliation |
State takmeel ut tib college and hospital |
| Address |
Department of niswan wa qabalat state takmeel ut tib college and hospital near ramabai rally sthal
Near ramabai rally sthal aurangabad
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
919632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariyam Roqaiya |
| Designation |
Assistant professor |
| Affiliation |
State takmeel ut tib college and hospital |
| Address |
Department of niswan wa qabalat state takmeel ut tib college and hospital near ramabai rally sthal
Near ramabai rally sthal aurangabad
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
919632560839 |
| Fax |
|
| Email |
dr.mroqaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| State takmeel ut tib college and hospital Near Ramabai rally sthat Aurangabad lucknow uttar pradesh |
|
|
Primary Sponsor
|
| Name |
State takmeel ut tib college and hospital |
| Address |
Near Ramabai rally sthal lucknow uttar pradesh India
226012 |
| Type of Sponsor |
Government medical college |
|
|
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 Farheen Fatima |
out patient department of niswan wa qabalat room number 111 |
State takmeel ut tib college hospital near ramabai rally sthal
Lucknow
UTTAR PRADESH |
918318902295
fatimafarheen692@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State takmeel ut tib college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N86||Erosion and ectropion of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habbul aas (Myrtus communis Linn berries) |
Decoction of Habbul aas (Myrtus communis Linn.) will be made by adding 12gm of Habbul aas in 1liter of water and then mixed in 4liter of plain water and will be used for the sitz bath daily in the morning for 14days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married women above 18 years
Cervical erosion on P/S examination
Normal/Inflammatory changes on Pap’s smear |
|
| ExclusionCriteria |
| Details |
Pregnant, lactating and menopausal women
Patients with systemic, endocrinal illness and history of malignancy
Patients with sexually transmitted diseases
Presence of abnormal growth on the cervix
Patients with other pelvic pathology
Patients on oral contraceptive pills and IUCDs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the subjective symptoms
Reduction in the cervical erosion score
Improvement in the quality of life (SF-12 score) |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life (SF-12 score) |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/07/2025 |
| Date of Study Completion (India) |
01/08/2026 |
| Date of First Enrollment (Global) |
12/07/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Patients meeting all the inclusion criteria will be given test drug daily in the morning for 14days. During treatment patients are advised to avoid sexual intercourse. Clinical parameters will be assessed on each visit. |