| CTRI Number |
CTRI/2026/03/106744 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Management of Endometriosis in Unani compound medicine specially pain in Endometriosis |
|
Scientific Title of Study
|
A Pilot Study On The Efficacy Of Unani Management In Endometriosis (Batan-E-Rehmiyat) With Chronic Pelvic Pain And Dysmenorrhea. |
| 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 AYSHA RAZA |
| Designation |
PROFESSOR |
| Affiliation |
A and U Tibbia College and Hospital |
| Address |
PG department of Qabalat wa Amraze Niswan, A and U Tibbia College and Hospital Ajmal Khan road karol Bagh 110005 Central DELHI 110005 India |
| Phone |
9354925031 |
| Fax |
|
| Email |
draysharaza11@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abdul Nasir |
| Designation |
Professor |
| Affiliation |
A and U Tibbia college and Hospital |
| Address |
Department of Jarahat, A and U Tibbia College and Hospital Ajmal Khan road karol Bagh 110005 Central DELHI 110005 India |
| Phone |
9354925039 |
| Fax |
|
| Email |
a.nasir.119@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abdul Nasir |
| Designation |
Professor |
| Affiliation |
A and U Tibbia college and Hospital |
| Address |
Department of Jarahat, A and U Tibbia College and Hospital Ajmal Khan road karol Bagh 110005
DELHI 110005 India |
| Phone |
9354925039 |
| Fax |
|
| Email |
a.nasir.119@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
A and U Tibbia college and Hospital |
| Address |
Ajmal khan road karol bagh delhi |
| 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 Aysha Raza |
A and U Tibbia Hospital |
OPD no. 14 and IPD of Amraze Niswan wa Qabalat , A and U Tibbia Hospital Central DELHI |
9354925031
draysharaza11@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: N719||Inflammatory disease of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon Dabeedulward and Arqe Brinjasif |
Majoon Dabeedulward 10 gm twice a day with arqe brinjasif 20ml twice daily for 3 months |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18–45 years,Diagnosed cases of endometriosis confirmed by USG or MRI,Complaints of dysmenorrhea and/or chronic pelvic pain,No hormonal or surgical treatment for endometriosis in the last three months,Willingness to participate and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
patient fails to follow instructions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain Assessment – Visual Analogue Scale (VAS)
2. Dysmenorrhea Severity Score
3. Menstrual Parameters
4. Quality of Life Assessment
|
base line , 15 days,30 days , 45 days and 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
|
|
|
Target Sample Size
|
Total Sample Size="6" Sample Size from India="6"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/04/2026 |
| 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="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A pilot interventional study is planned to evaluate the efficacy and safety of a Unani therapeutic regimen in the management of endometriosis Batana e Rehmiyat with special reference to chronic pelvic pain and dysmenorrhea. Endometriosis is a chronic estrogen dependent inflammatory disorder characterized by the presence of endometrial like tissue outside the uterine cavity, commonly affecting the ovaries, pelvic peritoneum and uterosacral ligaments, leading to symptoms such as chronic pelvic pain, dysmenorrhea, dyspareunia, infertility and reduced quality of life. Conventional management mainly includes hormonal therapy, analgesics and surgical interventions which often provide only temporary symptomatic relief and are associated with recurrence and adverse effects. In the Unani system of medicine the clinical presentation of endometriosis corresponds to Batana e Rehmiyat and conditions described under Waram al Rahim and Tashannuj al Rahim which arise due to derangement of temperament Su e Mizaj and accumulation of morbid humours Ghair Tabayi Akhlat in the uterus. The present open label pilot interventional study will be conducted in the Department of Qabalat wa Amraz e Niswan at A and U Tibbia College and Hospital. A total of six women aged 18 to 45 years with clinically and radiologically confirmed endometriosis will be included in the study. The intervention will consist of Unani medicinal therapy including Majoon Dabeedul Ward 10 g twice daily and Arq e Birinjasif 20 ml twice daily for a duration of three months. The primary outcome will be reduction in pelvic pain and dysmenorrhea assessed using the Visual Analogue Scale and dysmenorrhea severity score. Secondary outcomes will include assessment of menstrual parameters such as cycle regularity, duration and amount of menstrual flow, improvement in quality of life using a WHOQOL BREF based questionnaire, patient satisfaction and safety evaluation through clinical monitoring and laboratory investigations including complete blood count at baseline and at the end of the study. Baseline evaluation, monthly follow up and final assessment after three months of treatment will be performed. The study aims to assess feasibility, preliminary efficacy and safety of the Unani regimen and to generate preliminary evidence for further larger clinical studies in the management of endometriosis. |