| CTRI Number |
CTRI/2024/04/066505 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usefulness of the Homoeopathic medicines in Acute cases in General population. |
|
Scientific Title of Study
|
Scope of the modalities chapter of a Synoptic key of the materia medica by Dr. Cyrus Maxwell Boger in Acute cases |
| 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 Urvesh Kapadiya |
| Designation |
PG Scholar |
| Affiliation |
Smt A J savla homoeopathic medical college and research institute |
| Address |
OPD NO 15 Research Department ground floor Smt A J savla homoeopathic medical college and research institute
Pushpanjli building near district session court Mahesana
Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
8160638752 |
| Fax |
|
| Email |
urveshkapadiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malay Joshi |
| Designation |
Assistant Professor |
| Affiliation |
Smt A J Savla Homoeopathic medical college and research institute |
| Address |
PG Department of Homoeopathic Repertory and Case taking
Smt A J savla homoeopathic medical college and research institute
Pushpanjli building near district session court Mahesana
Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
9428000782 |
| Fax |
|
| Email |
shckalol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urvesh Kapadiya |
| Designation |
PG Scholar |
| Affiliation |
Smt A J Savla Homoeopathic medical college and research institute |
| Address |
OPD NO 15 Research Department ground floor Smt A J savla homoeopathic medical college and research institute
Pushpanjli building near district session court Mahesana
Gujarat
Mahesana
GUJARAT
384001
India |
| Phone |
8160638752 |
| Fax |
|
| Email |
urveshkapadiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt a j Savala homoeopathic medical College and research institute
Pushpanjali building near
District session court
Mahesana 384001
Gujarat
India
|
|
|
Primary Sponsor
|
| Name |
Dr Urvesh Kapadiya |
| Address |
OPD NO 15 Research Department
Ground floor Smt A J Savla homoeopathic medical college and Research Institute
Pushpanjali building near
District session court
Mehsana Gujarat |
| 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 urvesh kapadiya |
Smt a j savla homeopathic medical College and research institute |
OPD No 15
Pushpanjali building near district session court mahesana
Mahesana
GUJARAT |
8160638752
-
urveshkapadiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMT A J Savala homoeopathic medical College institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Induvidualized Homoeopathic Medicines |
Potency Centesimal Potency Dose as per the need of the case Medicine will dispence as per criteria frequency as per need of the case route of administration oral route duration of the therapy as per need of the case |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients of acute disease with distincitve modalities patients from both genders all the ages including the paediatrics and old age group patient having episode of chronic disease |
|
| ExclusionCriteria |
| Details |
Patients suffering from the life threatening disease & who need emergency medical intervention patient having other medication for same illness patient who have not given consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done in a significant improved status quo and left 4 criteria |
Assessment will be done in a significant improved status quo and left 4 criteria |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="107" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/05/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 prospective pre test post test randomly selected cases of acute diseases as per the inclusion criteria and exclusion criteria from the outpatient by process of case takng Purpose of this study is to show reuce the severity and improvement in symptoms of acute case by assesement of symptoms into different four categories selection of the appropriate homoeopathic medicines with the help of the boger synoptic key follow up will take as per the need of the case |