| CTRI Number |
CTRI/2023/02/050000 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Homoeopathic medicines in the treatment of cases of tinea corporis (Fungal) |
|
Scientific Title of Study
|
Usefulness of individualized homoeopathic medicine in centesimal potency vis a vis LM potency in the treatment of tinea corporis: A comparative observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Gautam |
| Designation |
PG Scholar |
| Affiliation |
Bakson homoeopathic medical college & hospital |
| Address |
Department of homoepathic materia medica
Room number S2
2nd Floor
Bakson Homoeopathic Medical College and Hospital
36B phase 1 Knowledge Park Greater Noida
Gautam Buddha Nagar
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8174070130 |
| Fax |
|
| Email |
gautam8174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Gautam |
| Designation |
PG Scholar |
| Affiliation |
Bakson homoeopathic medical college & hospital |
| Address |
Department of homoepathic materia medica
Room number S2
2nd Floor
Bakson Homoeopathic Medical College and Hospital
36B phase 1 Knowledge Park Greater Noida
Gautam Buddha Nagar
NIL
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8174070130 |
| Fax |
|
| Email |
gautam8174@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
PG Incharge Guide HOD Department of Homoeopathic Materia Medica |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Post Graduation Cell
Room number G21
Ground floor
Bakson Homoeopathic Medical College and Hospital
36B phase 1 Knowledge Park Greater Noida
Gautam Buddha Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
ashraj1974@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson homoeopathic medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical college and hospital |
| Address |
Bakson Homoeopathic Medical College and Hospital
Room No G 22
Ground Floor
36B phase 1 Knowledge Park
Greater Noida
Gautam Buddha Nagar |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhishek Gautam |
Bakson Homoeopathic Medical College and Hospital |
Bakson Homoeopathic Medical College and Hospital
Room No G 22
Ground floor
36B phase 1 Knowledge park 1 Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
8174070130
gautam8174@gmail.com |
| Abhishek Gautam |
Dr. D P Rastogi Central Research Institiute for Homoeopathy |
A 1/1 Opposite HCL Sector 24 Noida
Gautam Buddha Nagar
UTTAR PRADESH |
8174070130
gautam8174@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Bakson Homoeopathic Medical College |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
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 |
Homoeopathic medicine in Centesimal potency |
Pill Form
Globule No 30
Route of Administration oral
Centesimal potency
first dose at the beginning of case.
repetition according to follow up. follow ups every 2 weeks for a period of 24 weeks. |
| Intervention |
Homoepathic Medicine in LM Potency |
Oral route of administration
liquid form (water as vehicle) in 100ml bottle
1 teaspoon is taken as 1st dose
1st dose will be given after case taking
repetition according to foollow up
follow up every 2 weeks for a period of 24 weeks.
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with the age group of 19 years to 59 years
2 Diagnostic criteria will be mainly based on clinical history, presentation and examination with the help of KOH test.
3 Patient taking prior medications or topical creams will be enrolled after wash out periods of 15 days |
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactating women.
2 Patient having tinea infection secondary to other complications like lichenification.
3 Immune suppressed patients with HIV or on chemotherapy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected reduction in 5 D Pruritus scale |
5 D Pruritus score will be done at baseline, 4 weeks, 8 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/03/2023 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized, open label, double arm trial, comparing the usefulness of individualized homoeopathic centesimal potency and LM potency in the management of Tinea corporis. The primary outcome will be to compare the changes in the lesions of Tinea corporis with individualized homoeopathic medicines in centesimal potency and LM potency using 5D Pruritus scale. 5D Pruritus Scale will be used at the baseline, and at the end of treatment or final follow up and the scores in both the groups will be compared and concluded accordingly. |