| CTRI Number |
CTRI/2025/01/079764 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Individualized Homoeopathic Medicines in Cases of Dermatophytosis |
|
Scientific Title of Study
|
Role of Individualized homoeopathic medicines in the management of Dermatophytosis assessed by Total symptoms score |
| 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 YAMINIBEN PRAVINBHAI PATEL |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF MEDICINE ROOM NO 6 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
7623083130 |
| Fax |
|
| Email |
yami1952000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIDHI KHAMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA ROOM NO 15 FIRST FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
8866130328 |
| Fax |
|
| Email |
khamarvidhi5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR YAMINIBEN PRAVINBHAI PATEL |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF MEDICINE ROOM NO 6 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
7623083130 |
| Fax |
|
| Email |
yami1952000@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001 |
|
|
Primary Sponsor
|
| Name |
DR YAMINIBEN PRAVINBHAI PATEL |
| Address |
DEPARTMENT OF MEDICINE ROOM NO 6 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001
|
| 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 YAMINIBEN PRAVINBHAI PATEL |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
DEPARTMENT OF MEDICINE ROOM NO 06 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT |
7623083130
yami1952000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESERCH INSTITUTE INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIVIDUALIZED HOMOEOPATHIC MEDICINES |
POTENCY VARIOUS
DOSE AS PER NEED OF CASE
FREQUANCY AS PER NEED OF CASE
ROUTE OF ADMINISTRATION ORAL
DURATION OF TREATMENT 8 MONTHS AS PER NEED OF CASE |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group Participant aged 20 TO 60 years
Gender Male and female
Patient will be selected on the basis of ICD 11 code of dermatophytosis 1F28
Patient who gave voluntary consent to be include in the study
|
|
| ExclusionCriteria |
| Details |
Cases of ringworm complicated with other skin complaint like Psoriasis Eczema Candidial infection Atopic dermatitis
Cases of ringworm in immuno compromised patient like AIDS HIV and who are taking immunosuppressive therapy or corticosteroid
Cases with other systemic illness like uncontrolled Diabetes mellitus
Patient who are taking any other medication such as oinments external application Allopathic Homoeopathic Ayurvedic etc for dermatophytosis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TOTAL SYMPTOMS SCORE TO ASSESS REDUCTION IN DERMATOPHYTOSIS SYMPTOMS |
TOTAL SYMPTOMS SCORE WILL BE ASSESSED AT THE BASELINE AND AT THE END OF TREATMENT UPTO 8 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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)
|
Completed |
| 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 PROSPECTIVE STUDY PRE TEST POST TEST ONE GROUP EXPERIMENTAL STUDY TO ASSESS THE ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES FOR 8 MONTHS IN 100 PARTICIPANTS WITH DERMATOPHYTOSIS THAT WILL BE CONDUCTED AS PER INCLUSION AND EXCLUSION CRITERIA FROM OUTPATIENT DEPARTMENT AND THE OUTCOME MEASURES WILL ASSESS BY TOTAL SYMPTOMS SCORE OF THE PATIENTS FOLLOW UP AS PER NEED OF CASE UP TO 8 MONTHS OF DURATION |