| CTRI Number |
CTRI/2025/03/082616 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of Sneha Agnikarma with Tila taila and Ruksha Agnikarma with Tamra shalaka after Shastra Karma(excision) in the management of Kadara (corn) |
|
Scientific Title of Study
|
A comparative clinical study of agnikarma 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 P Divya |
| Designation |
Post Graduate Resident in Shalya Tantra |
| Affiliation |
Dr. N.A.MAGADUM AYURVEDIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER, ANKALI |
| Address |
OPD NO. 04, Department of Shalya Tantra, Dr. N.A. MAGADUM AYURVEDIC MEDICAL HOSPITAL,ANKALI, TALUK-CHIKODI DIST-BELGAUM -591213
Belgaum
KARNATAKA
591213
India |
| Phone |
7892408708 |
| Fax |
|
| Email |
divyaputtagunta222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Duradundi Gudasi |
| Designation |
Professor and HOD Department of Shalya Tantra |
| Affiliation |
Dr.N.A.MAGADUM AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, ANKALI-591213 |
| Address |
Dr. N.A.MAGADUM AYURVEDIC MEDICAL COLLEGE,HOSPITAL
AND RESEARCH CENTER,ANKALI-591213
TALUK-CHIKODI,DIST-BELGAUM
Belgaum
KARNATAKA
591213
India
Belgaum
KARNATAKA
591213
India |
| Phone |
9743192805 |
| Fax |
|
| Email |
duradundi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Duradundi Gudasi |
| Designation |
Professor and HOD Department of Shalya Tantra |
| Affiliation |
Dr.N.A.MAGADUM AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, ANKALI-591213 |
| Address |
Dr. N.A.MAGADUM AYURVEDIC MEDICAL COLLEGE,HOSPITAL
AND RESEARCH CENTER,ANKALI-591213
TALUK-CHIKODI,DIST-BELGAUM
Belgaum
KARNATAKA
591213
India
Belgaum
KARNATAKA
591213
India |
| Phone |
9743192805 |
| Fax |
|
| Email |
duradundi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213 Taluk
chikodi, Dist Belgaum |
|
|
Primary Sponsor
|
| Name |
Dr P Divya |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital and Research
Center Ankali,Taluk-Chikodi, Dist- Belgaum - 591213 |
| 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 P Divya |
Dr.N.A.Magadum Hospital |
OPD.no.04,Department of Shalya Tantra,Dr. N.A.MAGADUM AYURVEDIC MEDICAL COLLEGE,HOSPITAL
AND RESEARCH CENTER,ANKALI-591213
TALUK-CHIKODI,DIST-BELGAUM
Belgaum
KARNATAKA |
7892408708
divyaputtagunta222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.NAMAMC-IEC |
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 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: sushruta samhita, Procedure details: (Procedure Reference: sushruta samhita, Procedure details: •Procedure will be carried out in Shalya Tantra minor OT under aseptic precautions. •Kadara (Corn) part will be cleaned with Savlon & painted with Betadine 5% W/V sol. •Will be draped with sterile hole towel. •Infiltration of 3 to 5 ml of 2% Xylocaine in surrounding of Corn. •With the help of scalpel elliptical incision will be taken, and Corn will be held with Allie’s tissue holding forceps and will be excised.•Group B: Ruksha Agnikarma with Tamra Shalaka, till Samyak Dagdha Lakshana appear. •Appropriate precautions will be taken to avoid production of Asamyak Dagdha (neither superficial nor deep burn). Treatment duration : 10 days Observation : Excision on 0 day 3rd 7th 14th day Follow up : After observation period once in a month for three consecutive months. ))
(1) Medicine Name: Triphala guggulu, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 10 Days | | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: sushruta samhita, Procedure details: (Procedure Reference: sushruta samhita, Procedure details: •Procedure will be carried out in Shalya Tantra minor OT under aseptic precautions. •Kadara (Corn) part will be cleaned with Savlon & painted with Betadine 5% W/V sol. •Will be draped with sterile hole towel. •Infiltration of 3 to 5 ml of 2% Xylocaine in surrounding of Corn. •With the help of scalpel elliptical incision will be taken, and Corn will be held with Allie’s tissue holding forceps and will be excised. •Group A: Sneha Agnikarma with Tila Taila, till Samyak Dagdha Lakshana appear. •Appropriate precautions will be taken to avoid production of Asamyak Dagdha (neither superficial nor deep burn). Treatment duration : 10 days Observation : Excision followed by agnikarma on 0 day 3rd 7th 14th day Follow up : After observation period once in a month for three consecutive months. ))
(1) Medicine Name: Triphala guggulu, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with the clinical features of Kadara (Corn) will be included
2.Subjects with single or multiple Kadara (Corn) on only sole part of foot. |
|
| ExclusionCriteria |
| Details |
1.Subjects who are contraindicated for Agnikarma.
2.Subjects with infected Corns.
3.Subjects with structural foot deformity, plantar warts, plantar fasciitis, fracture of foot.
4.Subjects suffering from uncontrolled systemic disorders like diabetes, leprotic ulcers, vascular anomalies, malignant conditions of foot will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Presence of Corn |
before treatment and on 105th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of Corn & no recurrence |
before treatment & on 105th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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 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
|
The study is being conducted to compare the effect of Sneha Agnikarma with Tila Taila and Ruksha Agnikarma with Tamra Shalaka in Kadara, after Chedana karma in both the groups, each comprising of 20 participants. The null hypothesis is that both Sneha
Agnikarma with Tila
Taila and Ruksha
Agnikarma with Tamra
Shalaka are ineffective in the management of Kadara
(Corn). The three alternative hypothesis are - 1. Sneha Agnikarma with
Tila Taila
is more effective than Ruksha
Agnikarma with Tamra Shalaka in
the management of Kadara (Corn). 2. Ruksha Agnikarma with
Tamra Shalaka is more effective than Sneha
Agnikarma with Tila Taila in
the management of Kadara (Corn). 3. Ruksha Agnikarma with
Tamra Shalaka is as effective as Sneha
Agnikarma with Tila Taila in
the management of Kadara (Corn). |