| CTRI Number |
CTRI/2025/04/084408 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A trial to study the effect of individualized homoeopathic medicine in cases of sudden onset of stomach and intestinal infection with the help of Dr. J. T. Kent homoeopathic material medica repertory. |
|
Scientific Title of Study
|
To study the role of individualized homoeopathic medicine in cases of acute gastroenteritis with the help of repertory of homoeopathic materia medica by Dr. J. T. Kent |
| 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 DIPIKABEN CHIMANLAL PARMAR |
| Designation |
M.D. Homoeopathic Repertory Postgraduate Student |
| Affiliation |
Ahmedabad Homoeopathic Medical College and Sainath Hospital |
| Address |
Department of Homeopathic Repertory,
Ahmedabad Homoeopathic Medical College,
Sainath Hospital,
Opposite Kabir Enclave,
Bopal Ghuma Road,
Ghuma, Ahmedabad - 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
9913766033 |
| Fax |
|
| Email |
2204072030002@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devangi G Pandya |
| Designation |
Professor and Postgraduate Guide of Homoeopathic Repertory |
| Affiliation |
Ahmedabad Homoeopathic Medical College and Sainath Hospital |
| Address |
Department of Homeopathic Repertory,
Ahmedabad Homoeopathic Medical College,
Sainath Hospital,
Opposite Kabir Enclave,
Bopal Ghuma Road,
Ghuma, Ahmedabad - 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
7600399549 |
| Fax |
|
| Email |
devangi.pandyaahmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR DIPIKABEN CHIMANLAL PARMAR |
| Designation |
M.D. Homoeopathic Repertory Postgraduate Student |
| Affiliation |
Ahmedabad Homoeopathic Medical College and Sainath Hospital |
| Address |
Department of Homeopathic Repertory,
Ahmedabad Homoeopathic Medical College,
Sainath Hospital,
Opposite Kabir Enclave,
Bopal Ghuma Road,
Ghuma, Ahmedabad - 380058
Ahmadabad
GUJARAT
380058
India |
| Phone |
9913766033 |
| Fax |
|
| Email |
2204072030002@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Homoeopathic Medical College and Sainath Hospital.
Parul University,
Opposite Kabir Enclave,
Bopal Ghuma Road,
Ghuma, Ahmedabad - 380058
|
|
|
Primary Sponsor
|
| Name |
DR DIPIKABEN CHIMANLAL PARMAR |
| Address |
M.D. Homoeopathic Repertory Postgraduate Student,
Department of Homoeopathic Repertory,
Ahmedabad Homoeopathic Medical College and Sainath Hospital.
Opposite Kabir Enclave,
Bopal Ghuma Road,
Ghuma, Ahmedabad - 380058
|
| Type of Sponsor |
Other [The principal investigator] |
|
|
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 DIPIKABEN CHIMANLAL PARMAR |
Sainath Hospital |
Sainath Hospital,
Medicine and Pediatrics division,
Department of Homoeopathic Repertory.
Ahmadabad
GUJARAT |
9913766033
2204072030002@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research-Sainath Hospital, Ahmedabad (IECHR-Sainath Hospital) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (2) ICD-10 Condition: K529||Noninfective gastroenteritis and colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
After case taking and totality of the symptoms formed.
It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition after case taking and repertorization. Each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated homoeopathic medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty
stomach; dosage and repetition depending upon the individual requirement of the cases. Route of administration : Oral.
Duration: Till the status of the patient changed to cured or improved as mentioned in the secondary outcome. |
| Comparator Agent |
Individualized Homoeopathic Medicine |
After case taking and totality of the symptoms formed. It is planned as administering indicated homeopathic remedies in centesimal potencies, as decided appropriate to the case or condition after case taking and repertorization. Each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated homoeopathic medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Route of administration : Oral. Duration: Till the status of the patient changed to cured or improved as mentioned in the secondary outcome. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Cases with pre-diagnosed or with clinical presentation of Acute Gastroenteritis |
|
| ExclusionCriteria |
| Details |
Cases with irregular follow-up
Cases with severe pathological disease
Cases with Vesikari Clinical Severity Scoring more than or equal to 11
Cases with pregnancy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vesikari Clinical Severity Score |
At the beginning and at the end of the treatment, at the interval of 3,5,7 days or as per requirement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cured -Sensation of well being mentally and physically with disappearance of all symptoms of acute gastroenteritis with score of vesikari clinical scoring system reduced to 0-1.
Improved - Decrease in intensity and frequency of presenting complaints with feeling of well being and score of Vesikari Clinical Severity Score reduced but not reached to 0-1.
Not improved - No change in complaints |
At the beginning and at the end of the treatment, at the interval of 3,5,7 days or as per requirement |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
18/04/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [2204072030002@paruluniversity.ac.in].
- For how long will this data be available start date provided 01-05-2025 and end date provided 30-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is randomized, participant blinded, single center trial to study the role of the individualized homoeopathic medicine in cases of acute gastroenteritis. In this study participants will be recruited as mentioned in inclusion and exclusion criteria. Case taking will be done according to the guidelines mentioned by Hahnemann in Organon of Medicine. After proper analysis and evaluation of symptoms of the case, totality of symptoms will be formed. Medicine will be selected after repertorization with Kent repertory. As an assessment tool Vesikari Clinical Severity Scoring System will be used. Remedy will be prescribed in various potencies as per the requirement. Follow up of each case will be taken at the interval of 3,5,7 days or as per the requirement. Primary and secondary outcomes will be measured as mentioned earlier. |