| CTRI Number |
CTRI/2025/06/088256 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study to evaluate the effect of Tilwaka Kshara as topical application in 30 participants for removing Warts and Skin Tags |
|
Scientific Title of Study
|
A single-arm, open-labelled clinical study to evaluate the effect of Tilwaka teekshna pratisaraneeya kshara in the management of Charmakeela |
| 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 Sreejith Satheesan |
| Designation |
Associate Professor Department of Shalyatantra |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and PG Centre Kattakada Thiruvananthapuram |
| Address |
Associate Professor
Department of Shalya tantra
Pankajakasthuri Ayurveda Medical College and PG Centre Kattakada
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447791353 |
| Fax |
|
| Email |
dr.sreejith.satheesan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priya K Yesudas |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and PG Centre Kattakada Thiruvananthapuram |
| Address |
Department of Shalya tantra
Pankajakasthuri Ayurveda Medical
College and PG Centre Kattakada
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
8075262851 |
| Fax |
|
| Email |
priyayesudas94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya K Yesudas |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and PG Centre Kattakada Thiruvananthapuram |
| Address |
Department of Shalya tantra
Pankajakasthuri Ayurveda Medical
College and PG Centre Kattakada
Thiruvananthapuram
Thiruvananthapuram
KERALA
695572
India |
| Phone |
8075262851 |
| Fax |
|
| Email |
priyayesudas94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College and PG Centre, Kattakada, Thiruvananthapuram, Kerala ,India. Pin 695572 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Student funded MD Project] |
|
|
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 Priya K Yesudas |
Pankajakasthuri Ayurveda Medical College and PG Centre |
OP Shalya tantra
Department Room No: H 04
Kattakada
Thiruvananthapuram
KERALA |
8075262851
priyayesudas94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) Pankajakasthuri Ayurveda Medical College and PG Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: CARMAKILAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Susrutha sutrasthana 11/7 , Procedure details: Materials required:
1. Tilwaka Teekshna Pratisaraneeya Kshara
2. Glass rod
3. Betadine solution
4. Surgical spirit
5. Sponge holding forceps
6. Surgical bowl
7. Spatula
8. Nimbu swarasa
9. Sterile gauze or cotton balls
10. Surgical gloves
Preoperative procedure
1. Subjects will be positioned in the operating theatre according to the specific site of the
lesion being treated.
2. Part preparation will be done with betadine solution and surgical spirit.
3. Unaffected skin will be covered with sterile gauze.
Operative procedure
1. Tilwaka Teekshna Pratisaraneeya Kshara will be smeared using a glass rod over the lesion
and left for Vakshatamatrakala (90 seconds)
Post operative procedure
1. After ascertaining samyak dagdha lakshana (Pakva Jambu Phala Varna), the site will be
washed with nimbu swarasa and dressing will be done with Jatyadi taila.
2. Subjects will be advised to schedule follow-up assessments to monitor changes at the site
after the procedure.
3. No oral medication will be prescribed either before or after the procedure.
4. Subjects will be advised to maintain local cleanliness. )
(1) Medicine Name: Tilwaka teekshna pratisaraneeya kshara, Reference: Susrutha sutrasthana 11/11 , Route: Topical, Dosage Form: Kshara, Dose: 0(NA), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with warts or skin tags on neck, upper limbs or lower limbs.
2.Subjects of age group 18 -60 years irrespective of gender, religion, occupation and socio-
economic status.
3.Subjects who are willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Skin lesions more than 5mm size.
2.Pigmented lesions, Neurofibroma, Genital warts and Plantar warts.
3.Subjects contraindicated for Pratisaraneeya ksharakarma.
4.Diagnosed with systemic conditions such as Tuberculosis, HIV, Diabetes mellitus,
Hypertension, Bleeding Disorders and Carcinoma.
5.Warts displaying features suggestive of a carcinomatous appearance.
6.Subjects taking anti-coagulants.
7.Subjects with a history of allergy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness, safety, and clinical applicability of Tilwaka Teekshna
Pratisaraneeya Kshara as a topical application in the management of Charmakeela.
1.Number of days taken for complete shedding of the lesion
2.Reduction in size of the lesion (in mm)
3.Scar assessment after healing |
Assessment of size of lesion will be done before treatment (0th day), 7th day and 14th day after treatment.
Scar assessment will be on 14th day and 21st day.
Follow up assessment will be done on 21st day after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| Date of Study Completion (India) |
29/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A SINGLE-ARM, OPEN-LABELLED CLINICAL STUDY TO EVALUATE THE EFFECT OF TILWAKA TEEKSHNA PRATISARANEEYA KSHARA IN THE MANAGEMENT OF CHARMAKEELA
Charmakeela is classified as one of the Kshudra rogas by Acharya Susrutha and Vagbhata. It occurs when vyana vata combines with kapha ,leading to the formation of hard , immobile ,peg-like growths on the skin’s surface , characterized by rough texture. In Ayurveda, Charmakeela which bears a striking resemblance to warts and skin tags. The most well known cause of warts is infection with the human papillomavirus ( HPV ). Warts and skin tags represent one of the most prevalent dermatological issues globally. The management of Charmakeela involves topical application of Kshara , Agni and Shastra. The aim of this proposed study is to evaluate the effect of Tilwaka teekshna pratisaraneeya kshara in the management of Charmakeela. The study will be conducted as an single -arm ,open labelled clinical trial without control group with 30 participants between the ages of 18 and 60 years ,regardless of gender ,who meet the specified inclusion and exclusion criteria. These participants are selected from both OP and IP Department of Shalyatantra, Pankajakasthuri Ayurveda Medical College & PG Centre Hospital , Kattakada , Thiruvananthapuram. The assessment of symptoms will primarily rely on clinical examinations. This study will examine the treatment of Charmakeela using topical application of Tilwaka teekshna Pratisaraneeya kshara. The procedure will involve single sitting. Assessments will be conducted before treatment ( 0th day), on 7th day and 14th day . Scar assessment will be done on 14th and 21st day. Follow up will be conducted on 21st day. Statistical analysis will be performed on the results obtained during the study to draw conclusions about the effectiveness of the treatment.
|