| CTRI Number |
CTRI/2024/10/074662 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Can homoeopathic medicines help alleviate stomach pain and discomfort in people with gastritis, and if so, how much improvement can be expected? |
|
Scientific Title of Study
|
A QUASI EXPERIMENTAL STUDY ON THE EFFECT OF HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF GASTRITIS BY ASSESSING GASTROINTESTINAL SYMPTOM RATING SCALE |
| 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 Arya K V |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Practice of Medicine
Government Homoeopathic Medical College Karaparamba Kozhikode
NIL
Kozhikode
KERALA
673010
India |
| Phone |
08289853953 |
| Fax |
|
| Email |
aryaraghav04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lizmy Jose |
| Designation |
Guide, BHMS,MD(HOM) Professor(CAP),Department Of Practice Of Medicine |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Practice of Medicine
Government Homoeopathic Medical College Karaparamba Kozhikode
NIL
Kozhikode
KERALA
673010
India |
| Phone |
9447551747 |
| Fax |
|
| Email |
lizmyajith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lizmy Jose |
| Designation |
Guide, BHMS,MD(HOM) Professor(CAP),Department Of Practice Of Medicine |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Practice of Medicine
Government Homoeopathic Medical College Karaparamba Kozhikode
NIL
Kozhikode
KERALA
673010
India |
| Phone |
9447551747 |
| Fax |
|
| Email |
lizmyajith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College Kozhikode-673010,Kerala,India |
|
|
Primary Sponsor
|
| Name |
Dr Arya K V |
| Address |
Post Graduate Student Department of Practice of Medicine, Government Homoeopathic Medical College Kozhikode-673010, Kerala, India |
| Type of Sponsor |
Other [self] |
|
|
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 Arya K V |
Government Homoeopathic Medical College Kozhikode, Research OP Department OP Room Number 9 |
Research OP
Department OP Room
Number 9 Government Homoeopathic Medical College Karapparamba p.o, Kozhikode
Kozhikode
KERALA |
08289853953
aryaraghav04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical College, Kozhikode, Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K297||Gastritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic medicines |
After assessing the totality of symptoms of each patient, consider the most suitable homoeopathic medicine, weekly one dose orally for 6 months with the help of proper repertory |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Endoscopically confirmed cases of Gastritis.
2. Age between 18 and 65 years of both sexes |
|
| ExclusionCriteria |
| Details |
1. Patients with congenital abnormalities in GIT.
2. Pregnant and lactating mothers.
3. History of previous gastrointestinal surgery, Gastric cancer.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Title: Reduction of Gastrointestinal Symptom Rating Scale
Description: Gastrointestinal Symptom Rating Scale baseline score – Gastrointestinal
Symptom Rating Scale final score.
|
Interval: 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
12/10/2024 |
| 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="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
|
Clinical evaluation of constitutional homoeopathic medicines for the management of Gastritis by assessing Gastrointestinal Symptom Rating Scale before starting intervention and after 6 months of treatment. Evaluation done by assessing reduction in the score |