| CTRI Number |
CTRI/2023/05/053117 [Registered on: 24/05/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY OF RUBRICS OF RINGWORM FROM KNERR REPERTORY |
|
Scientific Title of Study
|
TO VERIFY CLINICAL UTILITY OF RUBRICS OF RINGWORM FROM KNERR REPERTORY: INTERVENTIONAL UNCONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KHUSHALI KUBERBHAI PATEL |
| Designation |
STUDENT |
| Affiliation |
DR V H DAVE HOMEOPATHIC MEDICAL COLLEGE |
| Address |
22 KUVARIKA SOCIETY NEAR SHANTABA PARTY PLOT PAREVA CIRCLE PATAN
DR V H DAVE MEDICAL COLLEGE HAHNEMANN HOUSE AMUL DAIRY ROAD OPP ICICI BANK NANDANVAN SOCIETY POPATI NAGAR ANAND
Anand
GUJARAT
384265
India |
| Phone |
9512873492 |
| Fax |
|
| Email |
khushalip31112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MEERA SHAH |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT OF REPERTORY |
| Affiliation |
DR V H DAVE HOMEOPATHIC MEDICAL COLLEG |
| Address |
DR V H DAVE MEDICAL COLLEGE HAHNEMANN HOUSE AMUL DAIRY ROAD OPP ICICI BANK NANDANVAN SOCIETY POPATI NAGAR ANAND
DR V H DAVE MEDICAL COLLEGE HAHNEMANN HOUSE AMUL DAIRY ROAD OPP ICICI BANK NANDANVAN SOCIETY POPATI NAGAR ANAND
Anand
GUJARAT
388001
India |
| Phone |
9898692003 |
| Fax |
|
| Email |
dr.meerashah@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
KHUSHALI KUBERBHAI PATEL |
| Designation |
STUDENT |
| Affiliation |
DR V H DAVE HOMEOPATHIC MEDICAL COLLEGE |
| Address |
22 KUVARIKA SOCIETY NEAR SHANTABA PARTY PLOT PAREVA CIRCLE PATAN
DR V H DAVE MEDICAL COLLEGE HAHNEMANN HOUSE AMUL DAIRY ROAD OPP ICICI BANK NANDANVAN SOCIETY POPATI NAGAR ANAND
Anand
GUJARAT
384265
India |
| Phone |
9512873492 |
| Fax |
|
| Email |
khushalip31112@gmail.com |
|
|
Source of Monetary or Material Support
|
| HEALTH CENTER AT ANAND AGRICULTURAL UNIVERSITY |
| SMT S I PATEL (IPCOWALA) HOMEOPATHIC HOSPITAL
|
|
|
Primary Sponsor
|
| Name |
KHUSHALI KUBERBHAI PATEL |
| Address |
22 KUVARIKA SOCIETY NEAR SHANTABA PARTY PLOT PAREVA CIRCLE PATAN |
| 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 MEERA SHAH |
SMT S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL |
SMT S I PATEL (IPCOWALA) HOMOEOPATHIC HOSPITAL AND DR V H DAVE HOMOEOPATHIC MEDICAL COLLEGE AMUL DAIRY ROAD
Anand
GUJARAT |
9898692003
dr.meerashah@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECVHDHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMEOPATHIC REMEDY |
30 200 1M POTENCY, IN SINGLE DOSE AND REPETITION OF MEDICINE WILL BE DONE ON 7 15 21 DAYS INTERVAL AS PER REQUIREMENT OF CASE
MEDICINE WILL BE GIVEN ORALLY |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
DIAGNOSED CASES OR CASES WITH CLINICAL PRESENTATION OF RINGWORM
|
|
| ExclusionCriteria |
| Details |
CASES OF RINGWORM WITH AIDS
CASES OF RINGWORM COMPLICATED WITH OTHER SKIN COMPLAINT
CASES OF RINGWORM WITH SEVERELY IMMUNOCOMPROMISED STATE
CASES OF RINGWORM IN PREGNANT WOMEN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RINGWORM SYMPTOM SCORE |
FOLLOW UP WILL BE TAKEN ON 7 15 21 DAYS AS PER CASE REQUIREMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
03/06/2023 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NON YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SKIN DISEASES ARE MAJOR HEALTH PROBLEM AFFECTING A HIGH PROPORTION OF POPULATION OF INDIA SKIN DISEASE CAN PLACE A HEAVY EMOTIONAL AND PSYCHOLOGICAL BURDEN ON PATIENTS THAT MAY BE FAR WORSE THAN PHYSICAL IMPACT THE STUDY WILL BE EXPERIMENTAL AND INTERVENTIONAL UNCONTROLLED TRIAL A STUDY WILL BE CONDUCTED WITH 34 SAMPLES AND WHICH WILL BE SELECTED FROM 2 PROJECT SITE ON BASIS OF INCLUSION AND EXCLUSION CRITERIA THROUGH PURPOSIVE SAMPLING CONSENT WILL BE TAKEN OF CHOSEN CASES CASE TAKING WILL BE DONE ACCORDING TO GUIDELINES MENTIONED BY DR HAHNEMANN IN APHORISMS NUMBER 83 TO 104 FURTHER CASE PROCESSING WILL BE DONE USING ZOMEO SOFTWARE OR BOOK FORM OF KNERR REPERTORY TO DIFFERENTIATE GROUP OF MEDICINES HERING GUIDING SYMPTOM OF OUR MATERIA MEDICA WILL BE USED CHOSEN REMEDY WILL BE GIVEN IN VARIOUS POTENCY AS PER REQUIREMENT OF CASES. THE FOLLOW UP BE TAKEN USING RINGWORM SYMPTOM SCORE AT 7 15 OR 21 DAYS INTERVALAS PER CASE REQUIREMENT AFTER CESSEATION OF TREATMENT PATIENT WILL BE FOLLOWED UP FOR AT LEAST 3 MONTHS TO CHECK RELAPSE ANALYSIS OF RESULT WILL BE DONE ACCORDING TO RESPONSE OBTAINED AFTER TREATMENT THE PERCENTAGE CRITERIA FOR PARTICULAR CASE WILL BE OBTAINED WITH USE OF RINGWORM SYMPTOM SCORE STATISTICAL ANALYSIS WILL BE DONE WITH PAIRED T-TEST THE EXPECTED RESULT WILL BE EITHER SIGNIFICANT OR NO USEFULNESS OF RUBRICS OF RINGWORM FROM KNERR REPERTORY IN TREATING THE CASES OF RINGWORM |