| CTRI Number |
CTRI/2025/02/079950 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
02/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Unani Medicine and Conventional Therapy for H. pylori induced Gastritis. |
|
Scientific Title of Study
|
A Comparative Randomized Clinical Study to evaluate the Efficacy of Unani formulations used in H.pylori induced Gastritis. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nida Saeed |
| Designation |
PG SCHOLAR |
| Affiliation |
Aligarh Muslim University |
| Address |
Department Of Jarahat Faculty of Unani Medicine Ajmal Khan Tibbiya College Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9354717822 |
| Fax |
|
| Email |
saaednida017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Tafseer Ali |
| Designation |
Professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Department Of Jarahat Faculty of Unani Medicine Ajmal Khan Tibbiya College Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7017474312 |
| Fax |
|
| Email |
tafseerali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nida Saeed |
| Designation |
PG SCHOLAR |
| Affiliation |
Aligarh Muslim University |
| Address |
Department Of Jarahat Faculty of Unani Medicine Ajmal Khan Tibbiya College Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9345717822 |
| Fax |
|
| Email |
saeednida017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Jarahat Faculty of Unani Medicine Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh India 202002 |
|
|
Primary Sponsor
|
| Name |
Department Of Jarahat AKTC AMU |
| Address |
Faculty of Unani Medicine Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh India 202002 |
| 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 Nida Saeed |
Ajmal Khan Tibbiya College Hospital |
Department of Jarahat
Faculty of Unani
Medicine Aligarh
Muslim University
Aligarh
Aligarh
UTTAR PRADESH
Aligarh
UTTAR PRADESH |
9354717822
saeednida017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ajmal Khan Tibbiya College Faculty of Unani Medicine Aligarh Muslim University Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K296||Other gastritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard along with UF |
Combination of both above stated will be given for a prescribed duration [H.pylori kit for 14 days along with Unani formulations till three months after diagnosis. |
| Intervention |
Triple drug therapy |
Pylokit from Cipla Ltd. [containing tablets of Tinidazole (500mg), Clarithromycin: (250mg), Lansoprazole:(30mg)]
One tablet of each will be given to the patients twice a day for 14 days after diagnosis. |
| Comparator Agent |
Unani Formulations |
Qurs-e-Gulnar (2 gm) will be prescribed along with Sharbat
Khashkhash (12 ml) and Arq Makoh (12 ml) twice a day will be given for three continuous months after diagnosis. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Endoscopic Diagnosis: H. pylori induced gastritis patients diagnosed on endoscopy using Rapidurease test (RUT) kit and histopathology.
Patient given written consent. |
|
| ExclusionCriteria |
| Details |
Patients of age below 14years.
Pregnant and lactating mothers.
Patient sensitive to any of the test or standard drugs included in the study will be excluded along with appropriate treatment, as and when required.
Severe Comorbidities: Participants with severe comorbidities such as advanced malignancies, severe cardiac, hepatic, renal diseases,Tuberculosis, Acute or Chronic Ulcerative colitis, Cohn’s disease, Positive case of Venereal disease, HIV and HBsAg in including Diabetes.
Allergies and Intolerances: Known allergies or intolerances to medications used for the treatment of upper GI inflammatory conditions or H. pylori eradication.
Already taken PPI [H.PYLORI] Kit |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Endoscopic findings
H. Pylori RUT kit
|
At the time of First visit and than after three months of the treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dyspepsia
Pain Abdomen
Heart burn
Melena
Dysphagia
Anemia
Indigestion
Belching
Nausea/ Vomiting
Flatulence |
2 weeks
1 month
3 month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Upper gastrointestinal (GI) inflammatory conditions are a group of disorders characterized by inflammation of the upper digestive tract. Endoscopy plays a vital role in confirming the diagnosis and assessing the severity of upper GI inflammatory conditions such as esophagitis, gastritis, duodenitis, and peptic ulcers thus, allowing for precise intervention strategies. The most common complaint of upper gastrointestinal disorders globally is dyspepsia. Dyspepsia according to RomeIII criteria should include 1 or more of the following 3 symptoms for 3 months within 6 months of symptoms initial onset. Upper GI symptoms like dyspepsia, heartburn, pain in abdomen and hematemesis are some of the common complaints with which patients present to the surgery OPD. Dyspepsia has a great socio-economic impact as it impairs the quality of life and adds to the financial burden due to repeated hospital visits and medications. |