| CTRI Number |
CTRI/2025/03/083357 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the outcomes of the polyherbal intervention in the symptoms of Diarrhoea dominant Irritable Bowel Syndrome |
|
Scientific Title of Study
|
A clinical study to evaluate the therapeutic efficacy of Safuf Zarishk in the management of Ishal Dimaghi (Diarrhoea dominant Irritable Bowel Syndrome) |
| 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 Shameem Ahmad Rather |
| Designation |
HOD and Professor Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM ), Srinagar |
| Address |
Department of Moalajat, Regional Research Institute of Unani Medicine Habak Naseem Bagh Campus Hazratbal Srinagar
Departmentof Moalajat, RRIUM Naseem Bagh campus of university of Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
HOD and Professor Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM ), Srinagar |
| Address |
Deparment of Moalalajat, Regional Research Institute of Unani Medicine Habak Naseem Bagh Campus of university kashmir, Hazratbal Srinagar
Department of Moalajat,RRIUM Naseem Bagh campus of university of kashmir Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tooba Bilal Wani |
| Designation |
PG scholar Moalajat |
| Affiliation |
Regional Research Institute of Unani medicine |
| Address |
Department of moalajat Regional Research Institute of Unani Medicine Habak Naseem Bagh Campus Hazratbal Srinagar
Department of moalajat ,Regional Research Institute of Unani Medicine Habak Naseem Bagh Campus Hazratbal Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
8491018733 |
| Fax |
|
| Email |
toobawani92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research In Unani Medicine(CCRUM),Headquarters, New Delhi ,110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research In Unani Medicine(CCRUM) New Delhi |
| Address |
Regional Research Institute Of Unani Medicine(RRIUM), University of Kashmir Srinagar, CCRUM New Delhi |
| 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 Shameem Ahmad Rather |
Regional Research Institute Of Unani Medicine |
Moalajat OPD , Ground Floor, department of Moalajat, RRIUM, Naseem Bagh campus, University of kashmir , hazratbal Srinagar
Srinagar
JAMMU & KASHMIR |
07889584083
shameem.rather.sr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,RRIUM,srinagar, RRIUM |
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 |
probiotic |
Powdered probiotic sachets containing
Lactobacillus (10 billion cells per sachet), 1.5g daily |
| Intervention |
Safuf ( Powder) |
It is a polyherbal preparation containing six herbal ingredients. These include
Suma q (Rhus coriaria L.), Sounth (Zingiber officinale
Rosc.), Ajwain (Trachyspermum ammi L.), Ana r Da na (Punica granatum
L.), Zarishk (Berberis vulgaris L.) and Baeru Ka Aata (Ziziphus mauritiana L.) 4.5 g of this powder will be given once a day with water for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as the cases of IBS-D as per the ROME IV criteria .
2. History of chronic recurrent symptoms and patient doesn’t have
adequate relief of the global IBS symptoms at the time of screening.
3. Normal screening tests |
|
| ExclusionCriteria |
| Details |
1• Deranged screening tests.
2• Acute onset of symptoms.
3• History of bleeding PR.
4• Nocturnal diarrhoea.
5• Weight loss associated with diarrhoea.
6• Known cases of colon carcinoma, celiac disease, lactose intolerance and
inflammatory bowel disease or any other organic disease of the GI
system.
7• Constipation dominant IBS.
8• Patients who had taken any type of medications for the relief of
diarrhoea and other symptoms at the time of screening including any
kind of probiotic, antibiotic or opioids.
9• Pregnancy and lactation, females planning for the pregnancy.
10• Uncontrolled hypertension and Diabetes.
11• Hepatic or kidney diseases |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in stool frequency.
2. Change in the stool consistency.
3. Change in stool urgency.
4. Improvement in abdominal pain
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Overall satisfaction with the treatment and improvement in associated symptoms like bloating and discomfort ( IBSS-S and Birmingham IBS system questionnaire)
2. Safety outcomes of the test drug ( through biochemical evaluation ) |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/04/2025 |
| 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="1"
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
|
Iritable Bowel Syndrome, also referred to as Functional Bowel Syndrome, is the cluster of symptoms including abdominal pain, bloating, diarrhoea, flatulence and constipation, in absence of any structural or inflammatory abnormalities . Since there are no reliable biological and structural markers that have been yet identified, the treatment therapy is assessed by the questionnaire. In the United states of America, it happens to be one of the top ten reasons for visits to the primary care physicians . Globally, about 10-20% of the adults and adolescents have symptoms in accordance with IBS symptoms . In the Kashmir valley, 24.9% of the general population is diagnosed with IBS . The global prevalence of IBS-D is 31.5% with ROME IV criteria The usual pharmacological treatment approach is on reducing symptom severity and the drugs used usually come with a lot of side effects. Also, less than one-third of IBS patients are satisfied with their present therapy, and 34% of them report no symptom management, therefore more potent treatments are neededThere needs to be the validation of more number of the safe and efficient unani drugs that act upon on the symptoms and synergistically target upon the hypothetical multifactorial pathologies. This approach will result in a long term relief, improve the burden of IBS-D related symptoms and improve the quality of life. This study will aim upon the same facts and hence a trial on efficacy of the unani formulation Safu f Zarishk will be evaluated, primarily on the stool urgency and frequency and secondarily on global IBS - D symptoms |