| CTRI Number |
CTRI/2025/08/093361 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [To study the effect of tagaradi vranropak tail in the management of padadari] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STUDY
STUDY OF EFFECT OF TAGARADI VRANROPAK TAILA IN THE MANAGEMENT OF PADADARI |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFECT OF TAGARADI VRANROPAK TAILA IN THE MANAGEMENT OF PADADARI WITH SPECIAL REFERENCE TO SUSHRUT SAMHITA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Nagkrishna Balaji Kompalwar |
| Designation |
PG Scholar |
| Affiliation |
Yashwantrao chavan ayurvedic medical College and hospital |
| Address |
Department of ayurved samhita and siddhant Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
8208219849 |
| Fax |
|
| Email |
nagkrishnakompalwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Nilesh Gajjewar |
| Designation |
Associate professor |
| Affiliation |
Yashwantrao chavan ayurvedic medical College |
| Address |
Department of ayurved samhita and siddhant Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
9767298807 |
| Fax |
|
| Email |
nileshgajjewar1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Nilesh Gajjewar |
| Designation |
Associate professor |
| Affiliation |
Yashwantrao chavan ayurvedic medical College |
| Address |
Department of ayurved samhita and siddhant Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
9767298807 |
| Fax |
|
| Email |
nileshgajjewar1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar 431007 |
|
|
Primary Sponsor
|
| Name |
Nagkrishna Balaji kompalwar |
| Address |
Department of Ayurved samhita and siddhant Yashvantrao Chavan Ayurvedic Medical College and Hospital Nipani Bhalgaon, Beed Bypass Rd Chhatrapati Sambhajinagar
Aurangabad Maharashtra, India. Pin code- 431007 |
| 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 |
| Vd Nagkrishna Balaji Kompalwar |
Vd Nagkrishna Balaji Kompalwar |
Department of samhita and siddhant Yashavantrao
Chavan Ayurvedic College and Hospital, Nipani Bhalgaon, Beed Bypass Rd, Chhatrapati Sambhajinagar 431007 Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA |
8208219849
nagkrishnakompalwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee Yashavantrao Chavan Ayurvedic College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L853||Xerosis cutis. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tagaradi vranropak tail, Reference: Sushrut samhita , Route: Topical, Dosage Form: Taila, Dose: 5(g), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 30 Days, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Crack N Heal Cream | Local application of crack N Heal cream on crack heels at bed time keeping over the night daily for for 30 days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 16 to 60yrs
Gender: Either
Subjects having crack heels |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of external application of tagaradi vranropak tail on padadari |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the literature of Padadari from Ayurvedic classics.
To compare the effect of Tagaradi vranropak Taila and Crack N Heal Cream in the management of padadari. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/08/2025 |
| 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
|
Skin diseases are mainly occurs due to lack of hygiene, habits And work place.Padadari is one such skin disease mentioned in Ayurvedic texts like Sushrut Samhita, Madhav Nidan, Vangsen Samhita etc.Acharya Sushrut has mentioned Padadari in Nidansthan kshudrarognidana. Padadari is a vatapradhanroga symptoms like Atichankraman that is walking for a long distance or long time on rough ground without using Footwear leads to Vataprakopa and causes increase in dryness at padatala(foot) and results in padadari(cracks on feet).In Padadari many small cracks are developed on foot sole and many times they are painful in nature. Farmers, housewives, field workers are more often prone to this diseases due to their habbits, type of work and lifestyle. Sushrut Samhita mentions various dravyas and formulations which have excellent vranropak or healing properties. Tagaradi Vranropak Tail is one such formulation mentioned in Sushrut Samhita Chikitsa Sthan Dvivraniya Chikitsa Adhyay. Considering the vranropaka or healing properties of Tagaradi Vranropak Taila and as padadari is a vatapradhan roga considering the vatashamak properties of Tagaradi vranropak taila. Local application of this Taila will be given to the patients to see the result. |