| CTRI Number |
CTRI/2025/03/082141 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic medicine in Alas (Athlets foot) |
|
Scientific Title of Study
|
An open randomized controlled clinical trial of kantakari siddha tail in the management of Alas (Athletes Foot) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Shrikrishna Tayde |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre, Ashta |
| Address |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- Sangli,Maharashtra, 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
8329202959 |
| Fax |
|
| Email |
taydeashish9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Patil |
| Designation |
HOD Department of ShalyaTantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre, Ashta |
| Address |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- Sangli,Maharashtra, 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Patil |
| Designation |
HOD Department of ShalyaTantra |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre, Ashta |
| Address |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- Sangli,Maharashtra, 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9422613195 |
| Fax |
|
| Email |
dr.patilmanoj77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre, Ashta Tal. Walwa Dist. Sangli, Maharshtra, India Pincode 416301 |
|
|
Primary Sponsor
|
| Name |
Dr. Ashish Shrikrishna Tayde |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre, Ashta Tal. Walwa Dist. Sangli, Maharshtra, India Pincode 416301 |
| 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 Ashish Tayde |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Reseach Centre |
OPD no.13, Shalyatantra OPD,Ground floor,Dhanvantari Ayurveda Hospital Ashta, Tal- Walwa,Dist- sangli,Maharashtra, 416301
Sangli
MAHARASHTRA |
8329202959
taydeashish9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved 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:L988||Other specified disorders of the skin and subcutaneous tissue. Ayurveda Condition: ALASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kantkari siddha Tail, Reference: Sushrut Chikitsa Sthan Chapter number 20,Shloka number 21,22, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole Lotion | Clotrimazole Lotion 1% BD, Local application (Topical) in sufficient quantity |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having all lakshnas of Alas vyadhi, caste, religion, and locality will be seleted, Patients having typical lakshana of Alasvyadhi, Patients will be selected of both sexes |
|
| ExclusionCriteria |
| Details |
Patients having kshudrarog other than Alasvyadhi, Patients having complications of Alas, Patients having all types of kushtaroga, Patient presenting with Alas suffering with any other systemic disorders like DM, TB, and HIV, Symptoms more than 1 year |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Kantakari Siddha Tail in the management of Alas |
05 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Kantakari Siddha Tail and Clotrimazole lotion, To review details about the Alas according to referance in Sushrut Samhita, To observe any adverse drug reaction of Kantakari Sidhha tail in
Management of Alas |
05 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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 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
|
This study is an Open Randomized controlled clinical trail comparing the safety and efficacy of Kantakari Siddha Tail in a sufficient quantity for local application and Controlled drug Clotrimazole Lotion 1% for 15 days in 64 patients of Alas (Athlet’s Foot) |