| CTRI Number |
CTRI/2025/04/085145 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Agnikarma in the treatment of corn |
|
Scientific Title of Study
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF GOGHRITA SNIGDHA AGNIKARMA IN THE MANAGEMENT OF KADARA |
| 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 SHILPA SURYAVANSHI |
| Designation |
PG SCHOLAR |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Vijayapura Karnataka |
| Address |
2nd YR PG Scholar BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Bagalkot road Vijayapura 586109 Karnataka
Dept of Shalya tantra OPD number 3 BLDEAs AVS Ayurveda Mahavidyalaya Bagalkot road Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
9731610724 |
| Fax |
|
| Email |
sksuryavanshi869@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRASADSHAKTI G GANNUR |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Vijayapura Karnataka |
| Address |
Dept of Shalyatantra BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Bagalkot road Vijayapura 586109 Karnataka
Dept of Shaly tantra OPD number 3 BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Bagalkot road Vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
9480062140 |
| Fax |
|
| Email |
pgannur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHILPA SURYAVANSHI |
| Designation |
PG Scholar |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Vijayapura Karnataka |
| Address |
2 nd Yr PG Scholar Dept of Shalya tantra BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Bagalkot road Vijayapura 586109 Karnataka
Dept of Shalya tantra OPD no 3 BLDEAs AVS Ayurveda Mahavidyalaya Hospital And Research Centre Bagalkot road Vijayapura 586109 Karnataka
Bijapur
KARNATAKA
586109
India |
| Phone |
9731610724 |
| Fax |
|
| Email |
sksuryavanshi869@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAS AVS Ayurveda Mahavidyalaya Hospital and research
Centre Bagalkot road Vidyanagar Murankeri Vijayapura 586109 Karnataka |
| BLDEAs AVS Ayurveda Mahavidyalaya Hospital and research center Bagalkot road Vijayapura |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shilpa Suryavanshi |
BLDEA s AVS Ayurveda Mahavidyalaya Hospital and research centre Vijayapur. |
Room number 3 OPD Dept of Shalyatantra Bijapur Karnataka
Bijapur
KARNATAKA |
9731610724
sksuryavanshi869@gmail.com |
| Dr SHILPA SURYAVANSHI |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and research Centre Vijayapura 586109 Karnataka |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and research
Centre Bagalkot road vidyanagar murankeri Vijayapura 586109 Karnataka
Bijapur
KARNATAKA |
9731610724
sksuryavanshi869@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee BLDEAs AVS AYURVEDA MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE VIJAYAPURA KARNATKA |
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 with the Nibandha sangraha and Nyayachandrika commentary edited by Vaidya Yadavji Trikamji Acharya Chaukhambha oriental publications Nidana sthana chapter 13 pg no 322 shloka no 30 and31, Procedure details: Utkartana Superficial excision of hyper keratinised tissue done with all the aseptic precautions Agnikarma will be done with tapta Goghrita for 3 sittings with gap of 7 days )
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita with the Nibandha sangraha and Nyayachandrika commentary edited by Vaidya Yadavji Trikamji Acharya Chaukhambha oriental publications Nidana sthana chapter 13 pg no 322 shloka no 30 and31, Procedure details: Utkartana Superficial excision of hyper keratinised tissue done with all the aseptic precautions Agnikarma will be done with tapta Tila taila for 3 sittings with gap of 7 days )
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria of kadara like PAIN
NODULE
TENDERNESS
|
|
| ExclusionCriteria |
| Details |
Pitta prakruti and agnikarma contraindicated persons
Associated with systemic disorders
Infected corn |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain and
Regression nodule size |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in tenderness |
45 days |
|
|
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)
|
02/05/2025 |
| 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="2"
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
|
The Study is a Randomised Comparative Clinical Study To Evaluate the Efficacy of Goghrita Snigdha Agnikarma in the Management of Kadara conducted in BLDEAs AVS AYURVEDA MAHAVIDYALAYA HOSPITAL AND RESEARCH CENTRE VIJAYAPURA KARNATAKA 586109 INDIA |