| CTRI Number |
CTRI/2022/01/039559 [Registered on: 19/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Profile of Ringworm in patients attending Homoeopathy OPD |
|
Scientific Title of Study
|
The Clinico-Epidemiological Profile of Dermatophytosis in Patients Attending Homoeopathic Consultation at Tertiary Care Centre of Bhopal: A Cross Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Kumar Dixit |
| Designation |
Medical Officer (Homoeopathy) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of AYUSH, AIIMS, Bhopal
AIIMS, Saket Nagar Bhopal
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
|
| Fax |
|
| Email |
ashish.ayush@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Kumar Dixit |
| Designation |
Medical Officer (Homoeopathy) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of AYUSH, AIIMS, Bhopal
AIIMS, Saket Nagar Bhopal
MADHYA PRADESH
462020
India |
| Phone |
|
| Fax |
|
| Email |
ashish.ayush@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Kumar Dixit |
| Designation |
Medical Officer (Homoeopathy) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of AYUSH, AIIMS, Bhopal
AIIMS, Saket Nagar Bhopal
MADHYA PRADESH
462020
India |
| Phone |
|
| Fax |
|
| Email |
ashish.ayush@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Saket Nagar, Bhopal (462020) |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Ashish Kumar Dixit |
AIIMS Bhopal |
R. No. 13, Homoeopathy OPD, Department of AYUSH, AIIMS
Bhopal
MADHYA PRADESH |
9599834711
ashish.ayush@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B35||Dermatophytosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
89.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed with dermatophytosis visited the homoeopathy outpatient department. Age limit and Sex bias will not be used and patients of any age group and both sexes will be included. |
|
| ExclusionCriteria |
| Details |
Patients on antifungal drugs during past 2 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Intensity of Pruritus on a 0-10 Numeric Rating Scale (NRS)
2. Dermatology Life Quality Index (DLQI) |
At Baseline, 4th week, 8th week and 12th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "103"
Final Enrollment numbers achieved (India)="103" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/01/2022 |
| Date of Study Completion (India) |
05/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/09/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Homoeopathy as an alternative therapy offers treatment for the various clinical subtypes of dermatophytosis. Many patients regularly seek homoeopathic consultations in the outpatient department (OPD) as evidenced by various case reports suggesting the therapeutic utility of homoeopathy. But the availability of scanty data on the prevalence and some associated 18 epidemiological factors of dermatophytosis in patients attending homoeopathy OPD for the alternative treatment prompted to take up the present study. |