| CTRI Number |
CTRI/2026/03/106608 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of chronic Diarrhea with Unani Medicine Qurse-Gulnar. |
|
Scientific Title of Study
|
Clinical Validation Study of Unani Pharmacopeial Formulation Qurs e Gulnar in Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IM/IBS-D/QG/CLNVAL/CCRUM/23-24, Version-01, 10-10-25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Younis I Munshi |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
South West
DELHI
110058
India |
| Phone |
09419086700 |
| Fax |
|
| Email |
younismunshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support: 1-Central Research Institute of Unani Medicine (CRIUM), Lucknow. 2- Regional Research Centre (RRC), Prayagraj. |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khem chand |
Central Research Institute of Unani Medicine, Lucknow |
Research OPD Room Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)), Post & village, BasahaKursi Road, Lucknow – 226026
Lucknow
UTTAR PRADESH |
9721320075
rajakdrkc474@gmail.com |
| Dr Ashok Kumar |
Regional Research Centre, Prayagraj |
Research OPD Room Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)), B-501/4, GTB Nagar,Opp. Dulhan Palace, Kareli, Prayagraj– 211016
Allahabad
UTTAR PRADESH |
9450619024
rrcallahabad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of CRIUM, Lucknow |
Approved |
| Institutional Ethics Committee of RRC, Prayagraj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K580||Irritable bowel syndrome with diarrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Qurs e Gulnar |
2 tablets (1 gm each) taken orally thrice daily with water after meals for 6 weeks (42 days). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Based on Rome IV criteria for IBS-D.
. Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
1. Related to defecation (Pain).
2. Associated with a change in frequency of stool.
3. Associated with a change in form (appearance) of stool.
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 and above 60 years.
2. Known cases of Malignancy, Inflammatory bowel disease (Ulcerative colitis, Crohns disease) and, acute conditions like cholera, gastro-enteritis. Intestinal obstructions, etc.
3. Patients with disease requiring long term treatment e.g., Tuberculosis, Hypertension, Diabetes Mellitus, Malignancy, Liver or Kidney dysfunction, Hypothyroidism, Hyperthyroidism.
4.Patients suffering from Amoebic dysentery.
5.Diagnosed cases of coeliac disease, bowel resection, other gastrointestinal disorder contributing to the diarrhea, unexplained weight loss or rectal bleeding.
6.Use of probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids.
7. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the signs and symptoms of Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)). Which will be assessed on the basis of IBS Severity Scoring Scale (IBS-SSS) and Gastrointestinal Symptom Rating Scale (GSRS-IBS). |
At baseline and every two weeks during the protocol treatment. (i.e., at 0, 2nd, 4th, and 6th week). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e.,Haemogram, LFT, KFT, stool and Urine R/M. |
At baseline, 2nd week and at the end of protocol treatment.( i.e., 0, 2nd and 6th week) |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="2"
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
|
This study is designed as a multi-centric open trial in patients with Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)) . After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria. The patients will be assessed clinically at baseline and every two weeks of the protocol treatment. (i.e., 0, 2th, 4th and 6th week) . This includes subjective assessment on the basis of improvement in the signs and symptoms . The total duration of treatment will be 06 weeks. Laboratory parameters for safety assessment will be conducted at baseline, 2nd week and on completion of the protocol therapy (i.e., 0, 2nd and 6th week).
Composition of Qurse Gulnar | S. No. | Ingredients | Botanical / Chemical Name | Quantity | | 1. | Gulnar | Punica granatum L. | 40 g | | 2. | Gil-e-Armani | Aluminium silicate | 40 g | | 3. | Samagh-e-Arbi | Acacia nilotica L. Wild ex. Del | 40 g | | 4. | Gul-e Surkh | Rosa damascene Mill | 30 g | | 5. | Aqaqiya | Acacia nilotica L. Wild ex. Del | 30 g | | 6. | Kateera | Cochlospermum religosum (L) Alston | 20 g | | 7. | Aabe Gulnar | Punica granatum L. | Q.S. |
|