| CTRI Number |
CTRI/2025/08/093377 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Tamra Shalaka Agnikarma and Rajata Shalaka Agnikarma In Skin Tag |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study to Evaluate the Efficacy of Tamra Shalaka Agnikarma over Rajata 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 |
DrPrasad Nandode |
| Designation |
PG Scholar |
| Affiliation |
Sdm trusts Ayurvedic medical College and Padma Ayurvedic Hospital and Research Centre And Post Graduation centre , terdal |
| Address |
Sdm trusts Ayurvedic medical College And Post Graduation centre , terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
07066432979 |
| Fax |
|
| Email |
prasadnandode98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrIshwar Kattewadi |
| Designation |
Professor and HOD |
| Affiliation |
Sdm trusts Ayurvedic medical College And Post Graduation centre , terdal |
| Address |
Sdm trusts Ayurvedic medical College And Post Graduation centre , terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
8123999487 |
| Fax |
|
| Email |
ishwarsk208@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrasad Nandode |
| Designation |
PG Scholar |
| Affiliation |
Sdm trusts Ayurvedic medical College And Post Graduation centre , terdal |
| Address |
Sdm trusts Ayurvedic medical College And Post Graduation centre , terdal
Bagalkot
KARNATAKA
587315
India |
| Phone |
7066432979 |
| Fax |
|
| Email |
prasadnandode98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sdm trusts Ayurvedic medical College And Post Graduation centre And Padma Ayurvedic Hospital Institutional Ethics Comittee for Reseearch on Human Subjects Shalya Dept ground floor , terdal -587315 |
|
|
Primary Sponsor
|
| Name |
Dr. Prasad Nandode |
| Address |
Sdm trusts Ayurvedic medical College And Post Graduation centre And Padma Ayurvedic Hospital , terdal -587315 |
| 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 Prasad Nandode |
Padma Ayurvedic Hospital And Research Centre |
Sdm trusts Ayurvedic medical College And Post Graduation centre , terdal
Sdm trusts Ayurvedic medical College And Post Graduation centre , terdal
Bagalkot
KARNATAKA |
07066432979
prasadnandode98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMt Ayurvedic medical College and Padma Hospital Institutional Ethics Committee for Research |
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 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita, Procedure details: Agnikarma )
| | 2 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita, Procedure details: Agnikarma)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects Fulfilling the clinical features of Charmakeela |
|
| ExclusionCriteria |
| Details |
Patient with Bleeding Diseases
k/c/o-DM /HTN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Access the effect of Tamra Shalaka Agnikarma over Rajata Shalaka Agnikarma on Charmakeela |
To Access the effect of Tamra Shalaka Agnikarma over Rajata Shalaka Agnikarma on Charmakeela |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fast and Healthy wound Healig After Excision |
7th,14th,21st |
|
|
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 3 |
|
Date of First Enrollment (India)
|
31/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/08/2025 |
| 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
|
Skin is the body’s largest organ and acts as protection against germs, regulates body temperature. Charmakeela manifest on the Twak. Twak is the one among the panchendriya adisthanas.2 Twak having the 7 layers according to Shushrut. Avbhasini ,Lohita ,Shweta ,Tamra ,Vedini ,Rohini ,Mamsadhara3. No one is specified the adishthan of Charmakeela in relate to any specific layer of Twak. Warts is a benign growth that can developed on the skin and mucosa. It is most common viral infectious condition caused by human papilloma virus. They are harmless but can be bothersome, having symptoms like small fleshy grainy bumps, white, pink or tan coloured, sprinkled with black pinpoint which are small measuring about 1-10mm. Ugly looking skin has psychological impact may have un socialism, depression, and loss of confidence. Charmakeela is described under the Kshudraroga’s. Acharya Shushrut explained about the lakshana’s of Charmakeela as Kathin, Krushnavarna, Unnat, Mashebhya. Acharya Shushrut, Bhavprakash principles treatment for Charmakeela is Chedana9 followed by Dahana Karma and Dahanopakarma consists of Pippali, Shalaka, Kshara7. Chedana Karma9 is one among the Ashtavidha Shashtrakarma9. The diseases which are incurable by Shashtrakarma and Ksharakarma can be easily cured by Agnikarma10. The disorders treated by Agnikarma are said to have no recurrence. Many Research work has been done on Charmakeela but Tamra Shalaka no research work has been carried on Tamra Shalaka Agnikarma for the management of Charmakeela. |