| CTRI Number |
CTRI/2025/04/085292 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [local application] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of kushthadi lepa application in the management of Dadru kushtha |
|
Scientific Title of Study
|
A randomized controlled clinical study on the role of Kushthadi lepa in the management of Dadru Kushtha with special reference to Dermatophytosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranav Shivaji Katkar |
| Designation |
BAMS PG Scholar Panchakarma |
| Affiliation |
LKR Ayurvedic college and Research Centre |
| Address |
Panchakarma OPD LKR Hospital P2 MIDC area Shendi Mal Gadhinglaj kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9130307014 |
| Fax |
|
| Email |
sanku99928@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanuja Gaikwad |
| Designation |
BAMD MD KAYCHIKITSA |
| Affiliation |
LKR Ayurvedic college and Research Centre |
| Address |
Panchakarma OPD LKR Hospital P2 MIDC area Shendi Mal Gadhinglaj kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7588335343 |
| Fax |
|
| Email |
gaikwadtanuja14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranav Shivaji Katkar |
| Designation |
BAMS PG Scholar Panchakarma |
| Affiliation |
LKR Ayurvedic college and Research Centre |
| Address |
Panchakarma OPD LKR Hospital P2 MIDC area Shendi Mal Gadhinglaj kolhapur 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9130307014 |
| Fax |
|
| Email |
sanku99928@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic college and Research centre, P2 MIDC area,shendri mal,Gadhinglaj- 416501 Kolhapur, maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr Pranav Shivaji Katkar |
| Address |
shaswat main road near highschool,At Post- Koulage Tal- Kagal Dist- kolhapur- 416235, maharashtra,India. |
| Type of Sponsor |
Other [self] |
|
|
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 Pranav Shivaji Katkar |
LKR Ayurvedic college and Research centre gadhinglaj |
Panchakarma OPD LKR Hospital P2 MIDC area Shendi Mal Gadhinglaj kolhapur 416502
Kolhapur
MAHARASHTRA |
9130307014
sanku99928@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LKR Ayurvedic college and Research centre gadhinglaj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections 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 | Procedure | - | lepa, लेप | (Procedure Reference: Dravyagun vidnyan uttarard Yadavji, Procedure details: lepa i.e local application of kushthadi lepa on affected site in between 7 am to 10 am once in a day for 21 days. )
(1) Medicine Name: kushthadi lepa , Reference: charak samhita chikitsa stan kushthachikitsa adhyay 7/93, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Itraconazole 1% ointment | Antifungal ointment i.e itraconazole 1% used for topical application on affected site |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients having signs and symptoms of Dadru i.e kandu,pidika,mandala,raga
2- Patients with tinea corporis,tinea cruris,tinea barbae.
3- Patient willing for treatment and having lakshanas of dadru. |
|
| ExclusionCriteria |
| Details |
1- Patients having pre-diagnised history like DM,HIV,TB.
2- Pregnant patients were excluded.
3- History of any adverse drug reaction.
4- History of angioedema.
5- Patients having any kind of chronic skin diseaselike leprosy, psoriasis.
6- Tnea unguium.tinea capitis,tinea pedis,tinea manum, tinea incognito.
7- Chronoc fungal infection more than 3 months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Kushthadi lepa in the management of Dadru kushtha with special reference to Dermatophytosis |
0,7th day,14th day,21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study about Kushthadi lepa
To study about Dadru kushtha |
3 weeks |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/04/2025 |
| 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="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 is randomised controlled clinical study on the role of Kushthadi lepa in the management of Dadru kushtha with special reference to DermatophytosisTotal 60 patients of age 20 to 40 of both sex will be selected and divided into 2 groups of each 30 patients i.e A and B which are trial and control groups respectively. Then group A will be given Kushthadi lepa for local application and group B will be given intraconazole 1% oinment for local application for 21 days. Data will be analysed and appropriate statistical test will be applied , result will be presented. |