| CTRI Number |
CTRI/2026/01/100283 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to identify visible skin patterns helpful in diagnosing fungal skin disease (Dadru) |
|
Scientific Title of Study
|
Development and validation of Dermatoscopic criteria for Dadru (Cutaneous Dermatophytosis) - A Cross
sectional diagnostic accuracy study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jisha Shaji |
| Designation |
PG Scholar |
| Affiliation |
V P S V Ayurveda College, Kottakkal |
| Address |
Department of Agadatantra VPSV Ayurveda College, Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9048147658 |
| Fax |
|
| Email |
jishashaji1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P A Aboobaker |
| Designation |
Professor |
| Affiliation |
V P S V Ayurveda College, Kottakkal |
| Address |
Department of Agadatantra VPSV Ayurveda College, Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9037508922 |
| Fax |
|
| Email |
drpaaboobaker@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P A Aboobaker |
| Designation |
Professor |
| Affiliation |
V P S V Ayurveda College, Kottakkal |
| Address |
Department of Agadatantra VPSV Ayurveda College, Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9037508922 |
| Fax |
|
| Email |
drpaaboobaker@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda College Kottakkal |
| Address |
VPSV Ayurveda College, Kottakkal, Edarikode P O, Malappuram, Kerala, India, Pin 676501 |
| Type of Sponsor |
Other [Aided 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 |
| Dr Jisha Shaji |
VPSV Ayurveda College Hospital, Kottakkal |
Department of Agadatantra,VPSV Ayurveda College, Kottakkal
Edarikode P O, Malappuram, Kerala, India, Pin 676501
Malappuram
KERALA |
9048147658
jishashaji1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(IEC) VAIDYARATNAM P.S.VARIER AYURVEDA COLLEGE KOTTAKKAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically suspected lesions with
Raised circular lesions with well defined elevated border
Erythematous patches or areas of hypopigmentation/hyperpigmentation
2.Age 18 – 70 years, irrespective of gender.
3.Willingness to provide consent for participation in the study, including dermatoscopic examination
and KOH mount. |
|
| ExclusionCriteria |
| Details |
1.Lesions located exclusively on the scalp, face, nails, groin, palms, or soles.
2.Individuals currently receiving topical steroid therapy or who have received it within the last 2 weeks.
3.Individuals with known immunosuppression (HIV, Post organ transplantation, Chemotherapy).
4.Patients with coexisting cutaneous lesions along with Dadru (Cutaneous dermatophytes).
5.Patient suffering from major systemic illness necessitating long term drug treatment (Rheumatoid
arthritis) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification and documentation of consistent dermatoscopic criteria observed in clinically suspected cases of Dadru (Cutaneous Dermatophytosis), assessed at the time of diagnosis. |
At the time of diagnosis, following dermatoscopic examination and KOH mount evaluation. It can be done only after taking dermatoscopic features of all the KOH positive Cases. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sensitivity & specificity of dermatoscopy for diagnosing Dadru (Cutaneous Dermatophytosis) using KOH mount microscopy as the reference standard & Inter-rater reliability of dermatoscopic feature identification assessed using Cohen’s Kappa statistic. |
At the time of diagnosis, following dermatoscopic examination & KOH mount evaluation,after collection of all the datas from 122 participants in the study. |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
14/01/2026 |
| 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 study is a prospective, cross-sectional diagnostic accuracy study conducted at the Agadatantra OPD of Vaidyaratnam P. S. Varier Ayurveda College Hospital, Kottakkal. The study aims to develop and validate dermatoscopic criteria for the diagnosis of Dadru (Cutaneous Dermatophytosis) by comparing dermatoscopic features with Potassium Hydroxide (KOH) mount microscopy as the reference standard. A total of 122 clinically suspected cases aged 18–70 years will be enrolled using consecutive sampling. Diagnostic accuracy parameters such as sensitivity, specificity, positive predictive value, negative predictive value, and inter-rater reliability will be assessed. |