| CTRI Number |
CTRI/2025/11/096779 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| 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
|
Clinical study to evaluate the efficacy of COMPOUND UNANI FORMULATION JAWARISH-E-TABASHEER in GERD |
|
Scientific Title of Study
|
A RANDOMISED TWO ARM ACTIVE CONTROLLED CLINICAL STUDY OF GASTRO ESOPHAGEAL REFLUX DISEASE (MARZ-E-INEKAS-E-HUMUZAT-E-MEDA WO MARI ) WITH COMPOUND UNANI FORMULATION JAWARISH-E-TABASHEER AND RABEPRAZOLE |
| 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 Amreen |
| Designation |
PG scholar |
| Affiliation |
Government Nizamia Tibbi College and Hospital |
| Address |
Government Nizamia Tibbi College
OP No 1 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar
Hyderabad TELANGANA 500002 India
Hyderabad
TELANGANA
500002
India |
| Phone |
7569687151 |
| Fax |
|
| Email |
dramreen1221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Abdul Khadir Hussaini |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and Hospital |
| Address |
Government Nizamia Tibbi College
Room no 215 and OP No 1 PG Department of Moalijat, Government Nizamia Tibbi College and General Hospital, Charminar Hyderabad
Hyderabad
TELANGANA
500002
India
Hyderabad
TELANGANA
500002
India |
| Phone |
9704888561 |
| Fax |
|
| Email |
drsakhussaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amreen |
| Designation |
PG scholar |
| Affiliation |
Government Nizamia Tibbi College and Hospital |
| Address |
Government Nizamia Tibbi College
OP No 1 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar.
Hyderabad TELANGANA 500002 India
Hyderabad
TELANGANA
500002
India |
| Phone |
7569687151 |
| Fax |
|
| Email |
dramreen1221@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital ,Charminar,Hyderabad |
|
|
Primary Sponsor
|
| Name |
PG Scholar Dept of Moalijat |
| Address |
Government Nizamia Tibbi College and Hospital
OP No 1 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad
Hyderabad TELANGANA 500002 India |
| 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 Amreen |
Government Nizamia Tibbi College |
Government Nizamia Tibbi College
OP No 1 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar.
Hyderabad TELANGANA 500002 India
Hyderabad
TELANGANA |
07569687151
dramreen1221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JAWARISH E TABSHEER |
5GMS BD WITH ARQ BADYAN 150ML AFTER MEALS WITH TWO FOLLOW UPS WITH INTERVAL OF 15 DAYS |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
RABEPRAZOLE |
20MG OD BEFORE MEALS FOR 30 DAYS WITH 2 FOLLOW UPS WITH AN INTERVAL OF 15 DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex
Age : 20-60 years.
Patient with following complains :Regurgitation, Heart burn, Epigastric Pain,Nausea ,Indigestion,Flatulence,Loss of appetite, Water brash, Heaviness in abdomen after meals.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Psychiatric patients
Uncontrolled diabetes
GERD due to LOS causes .
Patients with cardiac, respiratory, liver and renal dysfunction.
Patients with:
Bleeding disorders
Known peptic ulcers
Gastric carcinoma
Hiatus hernia
Crohn’s disease
Zollinger Ellison Syndrome
Esophageal strictures, stenosis
Other malignancies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the clinical efficacy of jawarish e tabasheer in cases of GERD |
once in 2-4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prevent from complications of GERD like peptic strictures, Barret’s esophagus, esophageal adenocarcinoma. |
Once in Two weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2025 |
| 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="0"
Months="2"
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
|
GERD (Gastroesophageal Reflux Disease):
GERD is a chronic condition where stomach acid frequently
flows back into the esophagus, causing irritation and inflammation. This occurs
due to weakness or relaxation of the lower esophageal sphincter (LES).
Key Symptoms are :-Heartburn (burning chest pain),
Regurgitation of food or sour fluid, Bloating, belching, Difficulty swallowing,
Chronic cough or sore throat
Jawarish-e-Tabasheer is a classical Unani formulation
traditionally used for strengthening the digestive system and reducing excess
heat and bile (Safra).
Since the chronic use
of PPIs in the management of GERD cause hypomagnesemia,osteoporosis ;the
efficacy of unani drug JAWARISH E TABASHEER is evaluated |