| CTRI Number |
CTRI/2025/04/084750 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Symptomatic effect of Aragvadha patra lepa in dadru kustha |
|
Scientific Title of Study
|
Single arm clinical study to evaluate the upashayaymak effect of Aragvadha patra lepa in Dadru kustha |
| 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 Aniket Bhimrao Jambilkar |
| Designation |
MD Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research CentreKodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training AndResearch Centre Kodoli
Tal Panhala Dist Kolhapur 416114
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli
Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9325060100 |
| Fax |
|
| Email |
aniket.jambilkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Sadashiv Patil |
| Designation |
HOD |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli
Tal Panhala Dist Kolhapur 416114
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli
Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423802308 |
| Fax |
|
| Email |
drashok.rognidan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Sadashiv Patil |
| Designation |
HOD |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423802308 |
| Fax |
|
| Email |
drashok.rognidan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Aniket Bhimrao Jambilkar |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114 |
| 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 Aniket Bhimrao Jambilkar |
Yashwant Dharmarth Rugnalay,Kodoli |
Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
9325060100
aniket.jambilkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurvedic College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aragvadha Patra lepa, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Lepa Churna, Dose: 15(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having sign & symptom of Dadru
2)Irrespective of gender, caste,religion & socioeconomic status |
|
| ExclusionCriteria |
| Details |
1)Patient having known history of disease like DM,HIV,TB
2)Pregnant patients will be excluded
3)History of any drug adverse reaction
4)Patients having any kind of chronic skin diseaseslike Psoriasis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the Upashayatmak Effect of Aragvadha Patra in Dadru Kushta |
14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No any |
- |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dadru kushtha falling within the category of fungal infections,is categorised into superficial and deep mycoses.Recent data indicates that the prevalence of dadru in india varies from 36.6% to 78.4%.So that Aragvadha Patra will be selected for managing Dadru Kushtha in this study. |