| CTRI Number |
CTRI/2025/02/080436 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand the effect of external application of Ksheeridruvalkadi paste in the patients with crack foot |
|
Scientific Title of Study
|
Clinical Trial to Evaluate the Efficacy of Ksheeridruvalkadi Lepa in the Management of Padadari |
| 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 Arun Pratap MD Ay |
| Designation |
Professor & HOD |
| Affiliation |
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre, Kattakada, Thiruvananthapuram. |
| Address |
Department of Kayachikitsa
Room no. CO 06
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre
Kattakada
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9567256333 |
| Fax |
|
| Email |
dr.arunpratap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arya Kallia K K |
| Designation |
Post Graduate Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre, Kattakada, Thiruvananthapuram. |
| Address |
Department of Kayachikitsa
Room no. CO 05
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre
Kattakada
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9497155753 |
| Fax |
|
| Email |
aryakrishnaraj99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arya Kallia K K |
| Designation |
Post Graduate Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre, Kattakada, Thiruvananthapuram. |
| Address |
Department of Kayachikitsa
Room no. CO 05
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre
Kattakada
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9497155753 |
| Fax |
|
| Email |
aryakrishnaraj99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College & Post Graduate Centre
Kattakada
Thiruvananthapuram
Kerala
India
695572 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Arya Kallia K K |
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre |
OP Kayachikitsa Department
Room no. -H 06
Pankajakasthuri Ayurveda Medical College & Post Graduate Centre
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA |
9497155753
aryakrishnaraj99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) Pankajakasthuri Avurveda Medical College & PG Centre Kattakada Thiruvananthapuram Kerala 695572 |
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: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangadhara Samhita, Procedure details: The affected foot is cleaned with lukewarm water and allowed to dry.
Then Ksheeridruvalkadi Lepa is applied uniformly over the plantar aspect of the feet till
all the fissures of feet get filled with Lepa for 45 minutes and clean it with moist cloth twice
daily for a period of 14 days.)
(1) Medicine Name: Ksheeridruvalkadi Lepa, Reference: Arogyakalpadrumam, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 3(mg), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having cracks/fissures in the feet with or without pain and/or itching will be
selected.
2. Subjects between the age of 18 and 60 years irrespective of gender and socio-economic
status.
3. Subjects who are willing to sign the consent form and agreeing to follow the protocol
of the study |
|
| ExclusionCriteria |
| Details |
1. Subjects with Skin diseases as secondary manifestations to systemic illness.
2. Subjects suffering from psoriasis, eczema, allergic conditions.
3. Subjects having Cellulitis or ulcers in the foot, discharge from cracks and suppurative
infections
4. Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To determine the efficacy of Ksheeridruvalkadi Lepa in reducing the pain associated with Padadari.
• To determine the efficacy of Ksheeridruvalkadi Lepa in reducing the number of cracks. |
Subjective parameters:
• Pain
• Itching
• Dryness
Objective parameters:
• Number of fissures
• Average length of fissures
• Average depth of fissures
Assessment will be done on 0th day, 8th day, 15th day and 30th day
Investigations:
Laboratory tests will be performed on 0th day which includes:
• Fasting Blood Sugar
• Blood Routine Examination with Erythrocyte Sedimentation Rate
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of Ksheeridruvalkadi Lepa in Subjects |
• Absolute Eosinophil Count
• Renal Function Test
• Liver Function Test
Tests will be performed on 0th day and 15th day
• Contact Allergy Test will be performed on 0th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Clinical Trial to Evaluate the Efficacy of Ksheeridruvalkadi Lepa in The Management of Padadari. Padadari is a common skin disease which is described in Kshudra Roga Adhikarana. It is caused due to vitiation of Vata dosha. It affects the people irrespective of age and gender. It is caused due to Atichankramana and aggravates by Vataprakopaka Ahara and Vihara. It is characterised by cracks/fissures in the feet with pain and dryness of feet. It mainly affects the heel of foot. It can be correlated to cracked foot or heel fissures. Ksheeridruvalkadi Lepa is a yoga from Arogyakalpadrumam, 16th chapter and is indicated in conditions like Vipadika, Padavadaranam (Crack foot), and Padadaha (burning sensation of foot). Ksheeridruvalkadi Lepa has Vatapittahara, Vranaropaka, Twakdoshahara properties which helps in Samprapti Vighatana of Padadari. The study is an attempt to clinically analyse the efficacy of Ksheeridruvalkadi Lepa in Padadari. The present study is an interventional study with pre- and post- test without control group. Consecutive subjects with signs and symptoms of Padadari belonging to age group 18 to 60 years, irrespective of gender, registered in OP Department of Kayachikitsa, Pankajakasthuri Ayurveda Medical College Hospital, satisfying the inclusion criteria will be recruited until attaining the sample size. After collecting baseline data, detailed history and examinations will be done using case record form. The selected 30 subjects will be given external application of Ksheeridruvalkadi Lepa twice daily for 45 minutes after cleaning the area with lukewarm water for a period of 14 days. Subjective parameters and objective parameters will be assessed on 0th day, 8th day, 15th day and 30th day. The results obtained will be analysed statistically and conclusion will be drawn. |