| CTRI Number |
CTRI/2025/09/094273 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on homeopathic treatment in management of tinea cruris in adults using Fifty Millesimal potency. |
|
Scientific Title of Study
|
Evaluating the efficacy of Fifty Millesimal potency in the management of Tinea cruris in age group of 15 to 75 years. |
| 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 Ganesh Vyankatrao Kendre |
| Designation |
PG Student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune |
| Address |
PG student, Department of Organon of medicine, ground floor, Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7775821352 |
| Fax |
|
| Email |
ganesh7775.gk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Vyankatrao Kendre |
| Designation |
PG Student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune |
| Address |
PG student, Department of organon of medicine, ground floor, Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7775821352 |
| Fax |
|
| Email |
ganesh7775.gk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ardeshir Jagose |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune |
| Address |
Professor, Department of organon of medicine, ground floor, Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820291108 |
| Fax |
|
| Email |
ganesh7775.gk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homeopathic OPD and IPD complex, Ground floor, Department of organon of medicine, Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ganesh Vyankatrao Kendre |
Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune |
Homeopathic OPD and IPD complex first floor, Department of organon of medicine, Dr D Y Patil Homoeopathic Medical College and Research Center Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
7775821352
ganesh7775.gk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D. Y. Patil Homoeopathic medical college and research centre Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B356||Tinea cruris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualise Homoeopathic Medicine |
Individualise Homoeopathic Medicine in Fifty Millesimal Potency as per the case |
| Comparator Agent |
NIL |
NOT APPLICABLE AS SINGLE ARM STUDY. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Infected area which covered inner thigh gluteal cleft and groin region only.
Clinically diagnosed cases.
Positive KOH examination.
|
|
| ExclusionCriteria |
| Details |
Patients with infection spread beyond groin region or other then groin region.
Below the age of 15 years and above the age of 75 years.
Cases with complication like Lichenification and eczema.
Patient having Tinea infection secondary to other auto immune disorders systemic diseases or patients on immune suppressive therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Intensity of Itching in affected part |
Reduction in Intensity of Itching in affected part |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Reduce the Discoloration of skin |
To Reduce the Discoloration of skin 5 to 6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2025 |
| 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 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 is a single arm experimental study to explores the efficacy of individualized homoeopathic medicines given in fifty millesimal potency to manage Tinea cruris in age group of 15 to 75 years. To assess the treatment effectiveness of Tinea cruris assessment scale will be used. 50 patients of tinea cruris that fulfil the diagnostic criteria and also confirmed by clinical features and clinical examination will be enrol in the study. |