| CTRI Number |
CTRI/2025/08/093447 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
This study includes 60 participants who are having cracked foot and the effect of leaves of the Kudane in the form of oil as application is analysed and the effect of drug is mainly observed when applied externally |
|
Scientific Title of Study
|
Phyto Pharmaceutical and Clinical Evaluation of leaves of Solanum torvum Swartz. in Vipadika (Foot Crack) - A Folklore Claim |
| 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 Aishwarya |
| Designation |
2nd Year PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
3/68 Santrupthi
near Canara light
Kenchenkere post
Kerekadu
Mulki 574154
Dakshina Kannada
KARNATAKA
574154
India |
| Phone |
9980756188 |
| Fax |
|
| Email |
aishwaryabhat31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumyashree K M |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of Dravyaguna Vijnana Alvas Ayurveda Medical College and Hospital
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481512824 |
| Fax |
|
| Email |
drsoumyashree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Kumari M U |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
OPD OF PG Department of Dravyaguna Vijnana
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9449331394 |
| Fax |
|
| Email |
anjalikumarimu2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
574227 |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya |
| Address |
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
Karnataka
574227 |
| 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 Aishwarya |
Alvas Ayurveda Medical College and Hospital |
PG Studies in the Department of Dravyaguna Vijnana
Alvas Ayurveda Medical College and Hospital
Vidyagiri
Moodubidire
Dakshina Kannada
KARNATAKA |
9980756188
aishwaryabhat31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethical Committee Alvas Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L00-L99||Diseases of the skin and subcutaneous tissue. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Solanum torvum Swartz , Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 14 Days, Reference: NA, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who will give written consent
2. Patients of either sex will be taken for the
study
3. Patients fulfilling the diagnostic criteria
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from systemic diseases like Diabetes mellitus and Hypertension
2. Foot crack associated with bleeding |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check the parameters and assess the symptoms
1. Raaji (length of lesions)
2. Pada Sphutana (number of cracks)
3. Ruksha (dryness)
To assess the efficacy of the drug |
At Day 0, Day 8, Day 15, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To check the parameters and asses the symptoms
1. Ruja (pain)
2. Kandu (itching)
3. Daha (burning sensation) |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="1"
Days="10" |
|
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
|
Based on the folklore claim the present study is planned to explore the potential efficacy of Solanum torvum Swartz leaves clinically in Vipadika H0 There is no statistical significance of Taila of Solanum torvum Swartz leaves in Vipadika H1 There is statistical significance of Taila of Solanum torvum Swartz leaves in Vipadika Randomly patients are assigned through computer generated random sequence table 60 Patients of either sex fulfilling the diagnostic criteria and inclusion criteria will be selected randomly and assigned into 2 groups of 30 each Group A Tila taila for topical application Group B Solanum torvum Swartz leaves taila for topical application The patients suffering from Vipadika attending the OPD and IPD of Alvas Ayurveda Medical College and Hospital Medical camps and other referrals will be taken up randomly for the clinical study |