| CTRI Number |
CTRI/2025/11/097733 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [post operative wound healing] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFICACT OF CHEDANA PASHCHAT DURVA TAILA AND JATYADI TAILA APPLICATION IN MANAGEMENT OF KADARA (CORN). |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF CHEDANA PASHCHAT DURVA TAILA AND JATYADI TAILA APPLICATION IN THE MANAGEMENT OF KADARA (CORN) |
| 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 LAVANYA L |
| Designation |
PG SCHOLAR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND POST GRADUATION CENTRE |
| Address |
OPD DEPARTMENT OF SHALYATANTRA FIRST FLOOR SDM TRUSTS AYURVEDIC MEDICAL COLLEGE AND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE ,DR SIDDHANT NAGAR,TERDAL,BAGALKOT
Bagalkot KARNATAKA 587315 India |
| Phone |
7892051369 |
| Fax |
|
| Email |
lavanyalnaik15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SUJATA B WADDAR |
| Designation |
PROFESSOR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND POST GRADUATION CENTRE |
| Address |
OPD DEPARTMENT OF SHALYATANTRA FIRST FLOOR SDM TRUSTS AYURVEDIC MEDICAL COLLEGE AND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE ,DR SIDDHANT NAGAR,TERDAL,BAGALKOT
Bagalkot KARNATAKA 587315 India |
| Phone |
8105401470 |
| Fax |
|
| Email |
sujata.bw@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SUJATA B WADDAR |
| Designation |
PROFESSOR |
| Affiliation |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND POST GRADUATION CENTRE |
| Address |
OPD DEPARTMENT OF SHALYATANTRA FIRST FLOOR SDM TRUSTS AYURVEDIC MEDICAL COLLEGE AND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE ,DR SIDDHANT NAGAR,TERDAL,BAGALKOT
Bagalkot KARNATAKA 587315 India |
| Phone |
8105401470 |
| Fax |
|
| Email |
sujata.bw@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDANTH NAGAR TERDAL BAGALKOT KARNATAKA 587315 |
|
|
Primary Sponsor
|
| Name |
DR LAVANYA L |
| Address |
SIDRAMAPPA DANIGOND MEMORIAL TRUSTS AYURVEDIC MEDICAL COLLEGE AND DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE DR SIDDANTH NAGAR TERDAL BAGALKOT KARNATAKA 587315 |
| Type of Sponsor |
Other [] |
|
|
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 LAVANYA L |
PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE |
OPD,DEPARTMENT OF SHALYA TANTRA,FIRST FLOOR,SDMT AMC DANIGOND POST GRADUATION CENTRE PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE,DR SIDDHANT NAGAR,TERDAL,BAGALKOTE Bagalkot KARNATAKA |
7892051369
lavanyalnaik15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMAT AMC AYURVEDIC MEDICAL COLLEGE AND PADMA AYURVEDIC HOSPITAL INSTITUTIONAL COMITTEE FOR REASEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L84||Corns and callosities. Ayurveda Condition: KADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: DR SHAILAJA SHRINIVASAN,SHARANGADHRA SAMHITA ,CHAUKAMBHA ORIENTALIA,VARNASI,4 TH EDITION 2005,MADHYAMAKHANDA,9 TH CHAPTER,VERSE 183,PAGE NO 239, Procedure details: DEPENDING ON THE SITE OF CORN POSITION WILL BE GIVEN TO PATIENT . CHEDANA KARMA OF CORN WILL BE DONE TILL THE LEVEL OF THE BASE. HEAMOSTASIS WILL BE ACHEIVED . DRESSING WILL BE DONE WITH JATYADI TAILA LOCALLY OVER THE EXCISED WOUND.)
| | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: ACHARYA VIDYADHARA SHUKLA AND PROFF.RAVIDATTA TRIPATI,CHARAKA SAMHITA PART 2,CHAUKAMBA SANSKRIT PRATISHTHANA ,DELHI.CHIKITSA STHA 25 TH CHAPTER,VERSE NO-93, PAGE NUMBER 615, Procedure details: DEPENDIN ON THE SITE OF CORN POSITION WILL BE GIVEN TO PATIENT . CHEDANA KARMA OF CORN WILL BE DONE TILL THE LEVEL OF THE BASE. HEAMOSTASIS WILL BE ACHEIVED . DRESSING WILL BE DONE WITH DURVA TAILA LOCALLY OVER THE ESCISED WOUND.)
|
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. PATIENTS WITH CLINICAL SIGNS AND SYMPTOMS OF KADARA WILL BE INCLUDED FOR STUDY.
2.PATIENTS WITH THE AFE GROUP 17-70 YEARS IRRESPECTIVE OF GENDER WILL BE TAKEN.
3.PATIENT WILLING TO SIGNAND GIVE CONSENT . |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WITH HIV HBSAG TB DM HTN
2PATIENT WITH ANY OTHER ILLNES WHICH RESERCHER FEELS IT INTERFERES THE INTERVENTION OF THE STUDIES. |
|
|
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 HEALING OF WOUND POST EXCISION OF KADARA |
7TH DAY,14 TH DAY,21ST DAY,28 TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SAFETY OF TRIAL DRUG AND ADVERSE DRUG REACTION OF SYMPTOMS OF KADARA |
7TH DAY,14 TH DAY,21ST DAY,28TH DAY |
|
|
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)
|
01/12/2025 |
| 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
|
India, a developing
country where majority of the population lives in villages and engaged in
manual work and careless about their foot care. Chances of trauma is more
common in these people due to ignorance or due to poor economic condition they
wear improper foot wear and defective foot ware and poor foot care can lead to
many diseases. Among them the common one is Kadara.Kadara is explained under “Kshudra
Rogas” which usually occurs at the site of constant pressure. Acharya Sushruta has explained Lakshanas of Kadara as Keelavat, Kathina(
hard), Granthi Madhya Unnata( raised
in middle), Kolamatra( kolaphala )
in size, Ruk (pain), Srava( discharge)Kadara can
be correlated to corn.
Corn is localized
hyperkeratosis of the skin. It can be painful particularly when rubbed orwhen the pressure is
put on the site. Corn has a deep central core which reaches to the deeper
layers of the skin. Hyperkerotic lesions of the foot (corns and
calluses) have been reported to affect 33-68% of people aged 65 or older. It is
usually white/ yellow/grey in color and is common in females. Most
of them are hard corns and soft corns occur in between the toes.Few preventive
measures such as soft shoes or soft pads
at pressure point of the sole and treatments like local application of
salicylic acid on corn, use of corn plaster and lastly excision of the corn. So we need a conventional method to encounter these problems more effectively.
So
here an attempt is made to evaluate the efficacy of Durva taila application after Chedana
Karma over Jatyadi Taila application in the management of Kadara (corn). |