| CTRI Number |
CTRI/2025/02/080021 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| 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 Shuktyadi Lepa in Cracked Heel |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHUKTYADI LEPA OVER MADHUSIKTHADI LEPA IN THE MANAGEMENT OF PADADARI W.S.R TO CRACKED HEEL |
| 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 HARINI |
| Designation |
PG Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
Bagalkot
KARNATAKA
587315
India |
| Phone |
7760606446 |
| Fax |
|
| Email |
harinireddy.vbr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAHADEV S BADIGER |
| Designation |
Professor and HOD |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
Bagalkot
KARNATAKA
587315
India |
| Phone |
9736701207 |
| Fax |
|
| Email |
drmsb123@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAHADEV S BADIGER |
| Designation |
Professor and HOD |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
KARNATAKA
587315
India |
| Phone |
9736701207 |
| Fax |
|
| Email |
drmsb123@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic
Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka |
|
|
Primary Sponsor
|
| Name |
DR HARINI |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka |
| 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 HARINI |
Padma Ayurvedic Hospital And Research Centre |
OPD Department Of Kayachikitsa Ground Floor SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma
Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal
Bagalkot
KARNATAKA |
07760606446
harinireddy.vbr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital INSTOTUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
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 | Procedure | - | lepa, लेप | (Procedure Reference: , Procedure details: Subjects will be instructed to keep the feet in luke warm water for 5-10minutes & to clean with the brush or foot scrapper.
Wrap with a clean cloth & allow the feet to dry.
After that Lepa should be applied uniformly over the feet till all the fissures of feet get filled with Lepa.
Loss of medicine is prevented by wearing socks.
)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: SHARANGADHARA, Procedure details: Subjects will be instructed to keep the feet in luke warm water for 5-10minutes & to clean with the brush or foot scrapper.
Wrap with a clean cloth & allow the feet to dry.
After that Lepa should be applied uniformly over the feet till all the fissures of feet get filled with Lepa.
Loss of medicine is prevented by wearing socks.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects presenting with classical signs and symptoms of Padadari and cracked heel of either gender will be selected.
2 Subjects between the age group of 18 – 60 years.
3 Subjects willing to sign the consent.
|
|
| ExclusionCriteria |
| Details |
1 Subjects with known case of Diabetes mellitus.
2 Subjects diagnosed with Vaipadika, plantar psoriasis, hyperkeratotic eczema and athlete’s foot.
3 Deep cracks associated with bleeding.
4 Any other illness which researcher feels that interferes the intervention of study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of trial drug on improvements in the
symptoms of Padadari (Cracked Heel) |
7day,15day,21day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of trial drug and Adverse Drug Reaction and Aggravation of Symptoms of Padadari (Cracked Heel) |
7day,15day,21day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/02/2025 |
| 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="0"
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
|
Cracked heel, also known as Padadari in Ayurveda, is a common condition characterized by dry, itchy skin, hardness, and cracks around the heel. This condition causes pain and discomfort, hindering daily activities. According to Ayurvedic principles, Padadari is a Vata-Pradhana Vyadhi, resulting from aggravated Vata dosha.
The prevalence of cracked heel ranges from 42-54% in individuals aged 15 and above, with a higher incidence in females, housewives, and farmers. Modern treatment options include moisturizers and heel repair products, such as occlusive agents and keratolytic agents.
Ayurvedic treatment principles for Padadari include Siravyadha, Snehana, Swedana, and Lepa. This study aims to compare the efficacy of Shuktyadi Lepa explained in Gadanighraha kustharogadhikara and Madhusikthadi Lepa explained by yogaratnakara in managing cracked heel. Shuktyadi Lepa has Vatahara, Vranaropaka, and Twakprasadaka properties, making it a potential treatment option. The study will evaluate and compare the efficacy of these two lepas in managing cracked heel, providing insights into the effectiveness of Ayurvedic treatment modalities. |