| CTRI Number |
CTRI/2026/02/103901 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clincal study to evaluate the efficacy of saindhavadi Taila mixed with Eranda Taila in padadari(cracked heels) |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF SAINDHAVADI LEPA MIXED WITH ERANDA TAILA IN THE MANAGEMENT OF PADADARI (crack heel). |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Somnath Gadhave |
| Designation |
M.D. Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
OPD NO. 05 GROUND FLOOR, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 Pune MAHARASHTRA
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
9665995976 |
| Fax |
|
| Email |
agadhave555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Bokade |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil college of ayurveda and research centre |
| Address |
Dr D Y Patil college of ayurveda and research centre, Sant Tukaram
nagar, pimpri, pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
09657222876 |
| Fax |
|
| Email |
vrushalikumbhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Somnath Gadhave |
| Designation |
Professor (Kayachikitsa) |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, SantTukaram Nagar, Pimpri, Pune, Maharashtra 411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
09665995976 |
| Fax |
|
| Email |
agadhave555@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO. 05 GROUND FLOOR, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 Pune MAHARASHTRA
Pune
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Somnath Gadhave |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, SantTukaram Nagar, Pimpri, Pune, Maharashtra 411018 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 Aditi Somnath Gadhave |
Dr D Y Patil college of ayurveda and research centre |
OPD NO. 05 GROUND FLOOR, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 Pune MAHARASHTRA
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
09665995976
agadhave555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr DYPCA and RC Institutional Ethics Committee Pimpri Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: saindhavadi lepa, Reference: Acharya Yogratnakar, (Hindi translation) by Vaidyalakshmi pati sastri, Edited by Bhisagratna brahmasankar sastri, Uttaradha, shuDrarog chikitsa, edition-2018, chaukhambha orientalia, varanashi, pg.no 279. Sharma P.V., Dravyaguna Vijnana, Chaukhambha Bharati Academy, Varanasi, 2018; (II). , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(mg), Frequency: hs, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. A known patient with cracks in heels will be included
Patient with sign and symptoms of padadari mentioned in classical and contemporary text such as dari (fissure), ruja (pain), daari (cracks), rookshatva (dryness), kadu (itching), daha (burning sensation).
|
|
| ExclusionCriteria |
| Details |
1. Patient associated with other type of kshudra roga.
2. Patient with chronic systemic illness like diabetes, psoriasis, eczema.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in number, length, width of dari.
2. Improvement in pain using Vas scale before and after treatment.
3. Decrease in surface area, daha, kadu, itching after treatment.
|
15 Days (7, 15 day)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decrease in surface area, daha, kadu, itching after treatment.
|
15 Days (7, 15 day) |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
27/02/2026 |
| 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 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
|
To study the effecacy of Saindhavadi lepa with eranda taila in the padadri. 3-5 gms of saindhavadi lepa is mixed with eranda taila applied at night daily. |