| CTRI Number |
CTRI/2024/08/072912 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment in Chronic Gastritis |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines in LM Potency in the management of Chronic 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 |
Dr Divya D |
| Designation |
Post Graduate Scholar, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kurichy, Kottayam |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, sachivothamapuram(P O), Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9597525978 |
| Fax |
|
| Email |
diviyadhanumoorthi12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sitharthan |
| Designation |
Principal, Professor, Head of Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kurichy, Kottayam |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, sachivothamapuram(P O), Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sitharthan |
| Designation |
Principal, Professor, Head of the Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kurichy, Kottayam |
| Address |
Department of Practice of Medicine, National Homoeopathy Research Institute in Mental Health, sachivothamapuram(P O), Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Kurichy, Sachivothamapuram P O, Kottayam, Kerala, India 686532 |
|
|
Primary Sponsor
|
| Name |
Dr.DIVYA.D |
| Address |
National Homoeopathy Research Institute in Mental Health,sachivothamapuram (P O), Kurichy, Kottayam |
| 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 Divya D |
National Homoeopathy Research Institute in Mental Health |
Outpatient and in-patient departments, Peripheral centers conducted by Department of Practice of Medicine, National Homoeopathy Research Institute in Mental
Health, Sachivothamapuram(P O),Kurichy, pin: 686532
Kottayam
KERALA |
9597525978
diviyadhanumoorthi12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- National Homoeopathy Research Institute in Mental Health |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K29||Gastritis and duodenitis, (2) ICD-10 Condition: K295||Unspecified chronic gastritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine in LM Potency |
Indicated Individualised Homoeopathic Medicine will be started from 0/1 followed by next higher potency, serially, as per need of the case. The medicine will be dispensed in the following manner, 3/4th of the 90 ml phial is filled with distilled water. One medicated globule of the desired potency is crushed with sugar of milk and added. To this solution, 10 drops of dispensing alcohol is added for preservation purposes. The patient will be advised to give 10 uniform forceful downward strokes to the phial every time they take the medicine. From this solution, one tablespoon is added to 45 ml of normal water and stirred well. One tablespoon of the solution is taken orally and the rest is thrown away. Depending upon the improvement of the patient which is evaluated monthly once during the follow up for 12 months, further potency will be selected. If there is no improvement, the case is retaken and studied to administer the indicated remedy starting from 0/1 potency. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Age between 18 to 70 years of any gender
2) Score of more than 3 in the gastrointestinal symptoms questionnaire
3) Endoscopically confirmed cases of chronic gastritis
|
|
| ExclusionCriteria |
| Details |
1) Patient with known congenital abnormalities in the Gastrointestinal system
2) Patient with Gastric ulcer, Duodenal ulcer, known gastric malignancy, previous history of
gastric surgery
3) Score between 80-96 in the Gastrointestinal symptoms questionnaire
4) Pregnancy and lactating mother
5) Patients with severe anemia, alcohol dependence, under Non-steroidal anti inflammatory
drugs(NSAIDs)
6) Patients with known serious systemic illness such as Malignant Hypertension, uncontrolled
diabetes, severe cardiac diseases, malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of reduction in severity of symptoms in Chronic Gastritis after administration of Individualised Homoeopathic Medicine in LM Potency is planned to be done every month using Gastrointestinal
symptoms questionnaire. |
Every month from baseline till the conclusion of the study( 12th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain reduction in Patients with chronic gastritis will be evaluated using visual analogue scale
after administration of the indicated Homoeopathic medicine in LM potency |
Every month from baseline till the conclusion of the study( 12th month) |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
02/09/2024 |
| 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="6"
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
|
This study is a Quasi-experimental study to determine the effectiveness of individualised Homoeopathic Medicines in LM potency in the management of Chronic Gastritis that will be conducted in OPD,IPD and peripheral units of the Department of Practice of Medicine at National Institute in Mental Health, Kottayam. The primary outcome measures will be reduction in severity of symptoms of Chronic Gastritis evaluated by using Gastrointestinal Symptoms Questionnaire every month during the follow-up. The secondary outcome will be Pain reduction in Patients with chronic gastritis that will be evaluated using visual analogue scale
after administration of the indicated Homoeopathic medicine in LM potency. It will provide insight towards alternative
treatments for chronic gastritis and the action of LM potency.
|