| CTRI Number |
CTRI/2024/11/076850 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Tinea corporis is a fungal skin infection having itchy red patches that affect daily life. Conventional antifungal treatments can cause resistance, while homeopathy have great result. |
|
Scientific Title of Study
|
A comparative study on the effect of Tellurium metallicum and Juglans regia in the cases of tinea corporis. |
| 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 Sagar Naik |
| Designation |
BHMS, PG Scholar |
| Affiliation |
Parul Institute of Homoeopathy and Research, Waghodia, Vadodara (Gujarat) |
| Address |
101(C) , medicine opd ,Parul Institute of Homoeopathy and Research, Waghodia, Vadodara (Gujarat)
Vadodara
GUJARAT
391760
India |
| Phone |
8839081359 |
| Fax |
|
| Email |
drsagarnaik7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babina Ningombam |
| Designation |
BHMS, MD(Hom), Assistant professor in Materia Medica |
| Affiliation |
Parul Institute of Homoeopathy and Research, Waghodia, Vadodara (Gujarat) |
| Address |
Parul Institute of Homoeopathy and Research, Waghodia, Vadodara (Gujarat)
Vadodara
GUJARAT
391760
India |
| Phone |
8787898567 |
| Fax |
|
| Email |
babina.ningombam27545@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Naik |
| Designation |
BHMS, PG Scholar |
| Affiliation |
Parul Institute of Homoeopathy and Research, Waghodia, Vadodara (Gujarat) |
| Address |
101(C) , medicine opd,Parul Institute of Homoeopathy and Research, Waghodia, Vadodara (Gujarat)
Vadodara
GUJARAT
391760
India |
| Phone |
8839081359 |
| Fax |
|
| Email |
drsagarnaik7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Homeopathy and Research Hospital, Parul University, waghodia, vadodara,391760, gujarat,India |
|
|
Primary Sponsor
|
| Name |
Dr Sagar Naik |
| Address |
Parul Institute of Homoeopathy and Research Waghodia, Vadodara, 391760 (Gujarat), India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sagar Naik |
Parul Institute of Homoeopathy and Research Hospital |
101 (C)-Medicine Opd,Parul Institute of Homoeopathy and Research Hospital, Ishwarpura, Parul University, Vadodara
Vadodara
GUJARAT |
8839081359
drsagarnaik7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PIHR IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Juglans Regia |
according to the susceptibility of the patients i will select the potency,30,200,1M potency BD for 15 days till 4 months |
| Intervention |
Tellurium Metallicum |
according to the susceptibility of the patients i will select the potency,30,200,1M potency BD for 15 days till 4 months |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age from 21 – 70 years.
2. Both sexes.
3. All socio-economic status.
4. Willing to give informed consent.
5. Recently diagnosed and pre diagnosed cases.
6. Those cases which have similar totality with Tellurium metallicum and Juglans regia.
|
|
| ExclusionCriteria |
| Details |
1. Age below 21 and above 70 years.
2. Patient who are unwilling to give consent to join the study.
3. Patients on topical / steroidal and systemic antifungal treatment within last 3 months.
4. Those patients with the immuno-suppressive disease or on immunosuppressive drugs.
5. Pregnant and lactating mothers.
6. Those cases which are associated with other skin diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the therapeutic effect of Tellurium Metallicum and Juglans Regia in patients with tinea corporis.
|
12 months for each patient and 4 months for observation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of treatment with Tellurium metallicum and Juglans regia on the quality of life of patients affected by tinea corporis. |
12 months for each patient and 4 months for observation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 compares the effects of two homeopathic remedies, tellurium metallicum and juglans regia, on tinea corporis, a fungal skin infection. It aims to evaluate their efficacy in treating the condition, highlighting differences in outcomes and providing insights into their therapeutic potential in homeopathy. |