| CTRI Number |
CTRI/2026/02/104270 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Ayurvedic Medicine In Dadru (Fungal Infection) |
|
Scientific Title of Study
|
An Open Randomized Controlled Clinical Trial Of Durva Haridra Malahara In Dadru With Special Reference To Tinea Corporis In Children |
| 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 Trupti Jalindar Gavade |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Taluka Walwa
District Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9890347267 |
| Fax |
|
| Email |
truptig2025@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Patil |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Floor no 4th Balrog Department Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Taluka Walwa District Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
8148364767 |
| Fax |
|
| Email |
drdeepika.infantcare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepika Patil |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Floor no 4th Balrog Department Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Taluka Walwa District Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
8148364767 |
| Fax |
|
| Email |
drdeepika.infantcare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduation And Research Center Ashta Tal Walwa Dist Sangli 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Trupti Jalindar Gavade |
| Address |
OPD No 16 Balrog OPD Dhanwantari Ayurved Hospital Ashta Tal Walwa Dist Sangli 416301 |
| Type of Sponsor |
Private 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 |
| Dr Trupti Jalindar Gavade |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
4th Floor Department Of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301
Sangli
MAHARASHTRA |
9890347267
truptig2025@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangli |
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 | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Durva Haridra Malahara, Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: 1% Clotrimazole ointment , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of age group between 5 completed years to 14 completed years
2)Individual who is co-operative for the study
3) Patients having lesions upto 6 in numbers |
|
| ExclusionCriteria |
| Details |
1)Patients having severe and chronic infection of Dadru Kushtha
2)Patients having other skin diseases
3)Patient having major systemic diseases like HIV, SLE,etc
4)Not willing for participating in study |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Durva haridra malahara is effective in management of Dadru kushta |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1% Clotrimazole ointment is effective in management of Dadru kushta |
7 days |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/03/2026 |
| 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
|
Skin disorders are increasingly common among children and significantly affect their physical health, emotional well-being, and social confidence, especially when lesions are visible. Durva Haridra Malahar is a classical Ayurvedic topical preparation containing Durva and Haridra, herbs known for their anti-inflammatory, anti fungal, antimicrobial and wound-healing properties, which aid in skin repair and regeneration. It is traditionally used for managing wounds, burns, and various skin conditions. The present study is designed to evaluate its therapeutic efficacy and pharmacological relevance. Although Tinea infections such as Tinea corporis are generally treated with oral and topical antifungal agents, prolonged use in pediatric patients may lead to challenges including high cost, potential adverse effects, and poor treatment compliance. |