| CTRI Number |
CTRI/2026/03/106257 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of tikshna palash kshara in the management of charmakeel (warts). |
|
Scientific Title of Study
|
Randomized Controlled Study to evaluate the efficacy of Tikshna Palash Kshara in the management of Charmakeel (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 Pooja Balasaheb Sankpal |
| Designation |
Post Graduate student |
| Affiliation |
Ashwin Rural Ayurved College Manchi hill Sangamner |
| Address |
Opd no 12 Shalyatantra department Ashvin Rural Ayurved college and hospital Preetisudhaji maharaj nagar At Manchi hill Post Ashvi bk Tal sangamner dist Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
7709940291 |
| Fax |
|
| Email |
poojasankpal98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Matin Shakil Shaikh |
| Designation |
Associate Professor |
| Affiliation |
Ashwin Rural Ayurved College Manchi hill Sangamner |
| Address |
Opd no 12 Shalyatantra department Ashvin Rural Ayurved college and hospital Preetisudhaji maharaj nagar At Manchi hill Post Ashvi bk Tal sangamner dist Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
9028040012 |
| Fax |
|
| Email |
dr.shaikhms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Balasaheb Sankpal |
| Designation |
Post graduate student |
| Affiliation |
Ashwin Rural Ayurved College Manchi hill Sangamner |
| Address |
Opd no 12 Shalyatantra department Ashvin Rural Ayurved college and hospital Preetisudhaji maharaj nagar At Manchi hill Post Ashvi bk Tal sangamner dist Ahamadnagar
Ahmadnagar
MAHARASHTRA
413714
India |
| Phone |
7709940291 |
| Fax |
|
| Email |
poojasankpal98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashvin Rural Ayurved college and hospital Manchi hill Tal sangamner dist Ahamadnagar 413714 |
|
|
Primary Sponsor
|
| Name |
DrPooja Balasaheb Sankpal |
| Address |
Opd no 12 Shalyatantra department Ashvin Rural Ayurved college and hospital Preetisudhaji maharaj nagar At Manchi hill Post Ashvi bk Tal sangamner dist Ahamadnagar413714 Maharashtra |
| 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 Pooja Balasaheb Sankpal |
Ashvin Rural Ayurved college and hospital, Manchi hill Sangamner |
Opd no 12 Shalyatantra department Ashvin Rural Ayurved college and hospital Preetisudhaji maharaj nagar At Manchi hill. Post Ashvi bk. Tal sangamner dist Ahamadnagar
Ahmadnagar
MAHARASHTRA |
7709940291
poojasankpal98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ashvin Rural Ayurved college Manchi hill Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B078||Other viral warts. Ayurveda Condition: CARMAKILAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Salicylic Acid and Lactic Acid | (1) Medicine Name: Salicylic Acid and Lactic Acid, Reference:Sharma S, Badyal DK, editors. Lippincott illustrated reviews: pharmacology. 2nd South Asian ed. New Delhi: Wolters Kluwer; 2020. p.217.
Dose: 00(NA), Frequency: sos, Bhaishajya kal: After meal, Duration: 12 days, anupana/sahapana: No, Additional information-No | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Palash kshara, Reference: Sushrut Sutrasthan 11/12, Route: Topical, Dosage Form: Kshara , Dose: 00(NA), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 12 Days, anupAna/sahapAna: No, Additional Information: -No |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of Charmakeel as well as Warts.
2. Patients between the age group of 15-40 years. |
|
| ExclusionCriteria |
| Details |
1. Deeply seated Warts
2. Genital Warts
3. Warts having carcinomatous appearance
4. Warts associated with any other skin manifestations.
5. HIV
6. Diabetes
7. STD’s
8. Other systemic illness
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of Tikshna Palash Kshara in the management of
Charmakeel |
14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of relief in symptoms & drug safety for administration |
14Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| 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
|
For the wart/ Charmakeel, there is no single treatment that is proven 100 % effective. There are different types of treatment modalities combined. If the wart does not get cured by the first line of management, like destructive therapy with salicylic application, etc, other than the last option is surgical excision. But it has its limitations of scaring, pain and a high rate ofrecurrence.An Ayurvedic Kshara application may be an alternative to surgery because of its benefits, including no scarring, less pain, an easy-to-do procedure and requiring less time hospitalisation. So, to understand its importance over the surgery and other options, we took into consideration the Kshara application therapy in Warts/Charmakeel. Nowadays, every person is trying to get relief with easy methods, less hospitalisation, and according to their convenience. The Kshara karma has its various advantages, like less intense post-operative pain, no bleeding, outpatient treatment, cost-effective, no risk for recurrence and infection, and no surgical complications like incontinence and stenosis. Hence Pratisarniya Kshara method, external application of Palash kshara, is taken for study to treat Charmakeel. |