| CTRI Number |
CTRI/2025/11/096922 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy Of Homoeopathic Medicine in Gastric Ulcer |
|
Scientific Title of Study
|
EFFICACY OF HOMOEOPATHIC REMEDIES IN THE MANAGEMENT OF GASTRIC ULCER:A RANDOMIZED CONTROLLED TRIAL. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHINAV MITTAL |
| Designation |
PG Scholar |
| Affiliation |
Sriganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Tantia University Sriganganagar Near Riico Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
7014727781 |
| Fax |
|
| Email |
abhimittal198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ABHINAV MITTAL |
| Designation |
PG Scholar |
| Affiliation |
Sriganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Tantia University Sriganganagar Near Riico Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
7014727781 |
| Fax |
|
| Email |
abhimittal198@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABHINAV MITTAL |
| Designation |
PG Scholar |
| Affiliation |
Sriganganagar Homoeopathic Medical College Hospital and Research Institute |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute Tantia University Sriganganagar Near Riico Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan
Ganganagar
RAJASTHAN
335002
India |
| Phone |
7014727781 |
| Fax |
|
| Email |
abhimittal198@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tantia University |
| Address |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute NEAR RIICO BUS STAND HANUMANGARH SRIGANGANAGAR |
| Type of Sponsor |
Private 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 |
| Abhinav Mittal |
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute |
Room No 100 Medicine OPD Sri Ganganagar Homoeopathic Hospital and Research Institute Near RIICO Bus Stand Hanumangarh Road Sri Ganganagar Rajasthan 335002
Ganganagar
Ganganagar
RAJASTHAN |
7014727781
abhimittal198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Sri Ganganagar Homoeopathic College Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K25||Gastric ulcer, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
The dose and vitality may vary according to susceptibility and sensitivity of Patient, the acute or chronic nature of the disease. In this trial dosage , repetition and dispensing will be as per need of case and guidelines ofthe organon of medicine. Reassessment will be done after 3 month.
Route of administration is Orally
Dose is 30,200 and 1M
|
| Comparator Agent |
Placebo |
Placebo will be administered in Homoeopathic gloubles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Between 18-60 Years
2.Both sexes male and female
3 Patient who will provide their written Consent for Research |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and Lactating Woman
2. Current Steroid/ NSAID user
3. Immunocompromised individuals
4. Ulcer Complication (Perforation/ Malignancy) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Favourable
1) Slight reduction in Pain
2) Decreased nausea, bloating, and early satiety |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
25/11/2025 |
| 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="1"
Months="0"
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
|
A Gastric Ulcer is a type of Peptic Ulcer that forms on the inner linning of the Stomach. It develops due to imbalance between aggressive factors like gastric acid and Pepsin, and the Protective mechanism of the gastric mucosa. The two most common causes are infection with H pylori and prolonged use of NSAID. Additional contributing factor include excessive alcohol intake smoking,stress and Medical condition such as Zollinger - Ellison syndrome
Clinically, Gastric mucosa usually present with epigastric pain, often described as a burning or gnawing sensation, which may worsen after eating - a key difference from duodenal ulcer. Other symptom include nausea, bloating early satiety, and in severe cases, gastrointestinal bleeding. Bleeding may manifest as vomiting blood or black, tarry stool |