| CTRI Number |
CTRI/2024/10/075176 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to Evaluate the Safety and Efficacy of compound Unani formulation in the Management of Gastritis |
|
Scientific Title of Study
|
An Open Labelled Randomised Active Controlled
Clinical Study Of Iltihab Ul Meda Bis Sabab Wa Taseerul Muzirrat Bil Advia (Drug Induced Gastritis) With
Compound Unani Formulation |
| 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 Shams Unnisa |
| Designation |
P G Scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
OP No 1 and OP No 122 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
7095612127 |
| Fax |
|
| Email |
2binteali19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Abdul Khadir Hussaini |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
Room no 215 and OP No 1 PG Department of Moalijat, Government Nizamia Tibbi College and General Hospital Charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9704888561 |
| Fax |
|
| Email |
drsakhussaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shams Unnisa |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
OP No 1 PG Department of Moalijat, Government Nizamia Tibbi College and General Hospital, Charminar Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
7095612127 |
| Fax |
|
| Email |
2binteali19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital Charminar Hyderabad Telangana 500002 India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and General Hospital |
| Address |
PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar 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 Shams Unnisa |
Government Nizamia Tibbi College and General Hospital |
OP No 1 PG Department of Moalijat Government Nizamia Tibbi College and General Hospital Charminar Hyderabad
Hyderabad
TELANGANA |
7095612127
2binteali19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K295||Unspecified chronic gastritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sufoof-e-Vaj |
Sufoof-e-Vaj 5 gm, BD, with water, before meals, for 60 days, with
4 follow ups at interval of 15 days |
| Comparator Agent |
Tab Pantoprazole 40mg
|
Tab Pantoprazole 40mg BD, with water, before meals, for 60 days, with
4 follow ups at interval of 15 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with following Complaints Of:
1. Epigastric Pain
2.Nausea
3.Vomiting
4.Indigestion
5.Heart Burn6. Loss of Appetite
6. Eructation
Patient with Drug History of NSAIDS for
more than 3months |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2. Patient with H.pylori
3.Uncontrolled hypertension and diabetes
4.Patients with:
Active GI bleed
Obstruction and perforation
Gastric carcinoma
5.Previous h/o smoking and alcohol
6.Recent use of antibiotics
7.Patients with renal, cardiac, pulmonary and other systemic diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To diagnose te patient based oh LDQ scale (leeds Dyspepsia quesionnare) and symptoms |
once in 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prove / show the comparative study results in cases of Drug Induced Gastritis |
once in 2 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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
|
In unani, gastritis or warm-e- meda, as unani physicians has mentioned the gastritis by different
names Hirqat-e-meda, Sozish-e-meda, warm-e-meda and iltehab-e-meda According to concept, warm-e meda is condition in which there is inflammation of mucous
membrane of stomach. The compound unani formulation Sufoof-e-Vaj (which has
been through pre clinical trail) is selected to prove its efficacy
in comparison with standard drug Pantoprazole in treatment
of drug induced gastritis Medication induced GI symptoms & endoscopic pathology
are commonly encountered in clinical practice.
Over 35 million people consume drugs daily & about 25% of
which may develop gastritis According to data published by
gastroenterology research done at National level it stated that
the total population who consume NSAIDs of which 30.08%
of patiets are seen with GI Complications. While awareness of GI adverse effects of some medications
are well recognized, other medications that are commonly
used and cause GI symptoms frequently such as metformin,
are arguably underappreciated
Medication produced symptoms by altering GI physiology
and by causing tissue damage To clinically evaluate the efficacy of Unani formulation in management of ILTIHAB-UL-MEDA BIS- SABAB WA TASEERUL-MUZIRRAT BIL- ADVIA (DRUG INDUCED GASTRITIS ) with sample size of 40 and 2 duration with some inclusion and exclusion criteria (mentioned in part-6) The study has been planned |