| CTRI Number |
CTRI/2025/08/093467 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Comparative Clinical Study on Participants with Charmakeela (Warts) to Evaluate the Outcome of Karanja Pratisarneeya Ksharakarma and Tamra Shalaka Agnikarma |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Karanja Pratisarneeya Ksharakarma and Tamra Shalaka Agnikarma in the Management of Charmakeela Warts
|
| 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 Shreya Shrikant Kakare |
| Designation |
Post Graduate Resident in ShalyaTantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali |
| Address |
Dr N A Magadum hospital Shayla tantra department OPD no 4
Dr N A Magadum Ayurvedic Medical Hospital shalya tantra department OPD no 4
Belgaum
KARNATAKA
591213
India |
| Phone |
7744029466 |
| Fax |
|
| Email |
shreyakakare9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalsange Pawan Basaveshwar |
| Designation |
Associate Professor of Shalya Tantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali |
| Address |
Dr N A Magadum Ayurvedic Medical Hospital shalya tantra department OPD no 4
Dr N A Magadum Ayurvedic Medical hospital shalya tantra department OPD no 4
Belgaum
KARNATAKA
591213
India |
| Phone |
8748035055 |
| Fax |
|
| Email |
ambiciouspawan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalsange Pawan Basaveshwar |
| Designation |
Associate Professor of Shalya Tantra |
| Affiliation |
Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali |
| Address |
Dr N A Magadum Ayurvedic Medical Hospital shalya tantra department OPD no 4
Dr N A Magadum Ayurvedic Medical College Hospital shalya tantra department OPD no 4
Belgaum
KARNATAKA
591213
India |
| Phone |
8748035055 |
| Fax |
|
| Email |
ambiciouspawan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N A Magadum Ayurvedic Medical College Hospital and Research Cente AnkaliPincode 591213 Taluka
chikodi District Belgaum |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Shrikant Kakare |
| Address |
Dr N A Magadum Ayurvedic Medical College Hospital and Research
Center Ankali 591213 Taluk-Chikodi, Dist- Belgaum |
| 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 Shreya Shrikant Kakare |
Dr N A Magadum Ayurvedic hospital |
Dr N A Magadum Ayurvedic Medical Hospital and Research Center OPD no 4 Ankali 591213 Taluk-Chikodi, Dist- Belgaum
Dr N A Magadum Ayurvedic Medical College Hospital and Research Center Ankali 591213 Taluk-Chikodi, Dist- Belgaum
Belgaum
KARNATAKA |
7744029466
shreyakakare9@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:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: CARMAKILAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Sutrasthana 10/12th Chapter, Vagbhata Nidansthana 7th chapter, Procedure details: Cautery with very Hot Tamra Shalaka at the base of Charmakeela till burnt until Samyak Dagdha Lakshanas are observed after that Shatadhauta Ghrita application Number of Sitting 1)
| | 2 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Sushruata Sutrasthana 11th chapter, Procedure details: Application of Karanja Pratisaraneeya Ksharakarma over the Charmakeela/warts with spatula,wait till Samyak Dagdha lakshnas appear.site washed with lemon juice & apply Shatadhauta Ghrita. Number of Sitting 1))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having age between 18-70 years
Irrespective of religion, sex and other socio-economic conditions fulfilling all the clinical features of common Warts |
|
| ExclusionCriteria |
| Details |
Warts present on the sensitive parts like genitals, eye lids, lips will be excluded
Patients with systemic disease and Uncontrolled DM and suffering from Malignant Disease
All the contraindications for Ksharakarma and Agnikarma
pregnant and lactating females childrens
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| For better cosmetic outcome with non-invasive procedure |
one sitting and after that monthly follow up for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to heal the scar of warts cosmatically |
30th day 60th day 90th 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
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2025 |
| 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="6"
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 Present Study Title A Comparative Clinical Study to Evaluate the Efficacy of Karanja Pratisaraneeya Ksharakarma and Tamra Shalaka Agnikarma in the Management of Charmakeela WSR to Warts will be Conducted on 40 Subjects with 20 in Each Group with Mentioned Objective and Subjective Parameters One Group will be Treated with Pratisaraneeya Ksharakarma and other Group with Agnikarma Assesment of Patient will be Done Before Treatment and after Treatment |