| CTRI Number |
CTRI/2025/11/097995 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of kshar panchak kshara sutra and apamarg kshar sutra ligation in management of wart |
|
Scientific Title of Study
|
A clinical study of kshar panchak kshara sutra ligation in management of charmakeel w.s.r. wart |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNarendra Thakur |
| Designation |
P.g Scholar shalya tantra |
| Affiliation |
Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal Madhya Pradesh |
| Address |
P.g Department of Shalya tantra,O.p.d no.7,Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7489494929 |
| Fax |
|
| Email |
dr.narendra87nikki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShraddha Sahkare |
| Designation |
Professor Department of Shalya tantra |
| Affiliation |
Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal Madhya Pradesh |
| Address |
P.g Department of Shalya tantra,O.p.d no.7,Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9326827421 |
| Fax |
|
| Email |
sakhare2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShraddha Sahkare |
| Designation |
Professor Department of Shalya tantra |
| Affiliation |
Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal Madhya Pradesh |
| Address |
P.g Department of Shalya tantra,O.p.d no.7,Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9326827421 |
| Fax |
|
| Email |
sakhare2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal M.P
Bhopal
Madhya Pradesh
462044
India
|
|
|
Primary Sponsor
|
| Name |
Dr.Narendra Thakur |
| Address |
P.g Scholar,Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal M.P
Bhopal Madhya Pradesh 462044 India |
| 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 |
| DrNarendra Thakur |
Rani Dullaiya Smriti Ayurved P.G. College Hospital Bhopal |
P.g Department of Shalya tantra,O.p.d no.7,Rani Dullaiya Smriti Ayurved Pg Evam Chikitsalaya,Barkhedi kalan,Bhopal M.p
Bhopal
Madhya Pradesh
Bhopal
MADHYA PRADESH |
07489494929
dr.narendra87nikki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Rani Dullaiya Smriti Ayurved P.G. College Hospital Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L029||Cutaneous abscess, furuncle and carbuncle, unspecified. Ayurveda Condition: CARMAKILAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Rastarngani, Procedure details: The patient will be laid down in a comfortable position.
Wart part will be Draped with sterile cut drape sheet after administering local anesthesia
(xylocaine2%)
By the help of ksharpanchak kshar sutra complete wart was transfixed & ligate
)
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Rastarangani, Procedure details: The patient will be laid down in a comfortable position.
Wart part will be Draped with sterile cut drape sheet after administering local anesthesia
(xylocaine2%)
By the help of Apamarga kshar sutra complete wart was transfixed & ligate
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of (Charmakeel) wart .
Those patients of charmakeel who will be medically fit for ksharsutra ligation irrespective of gender, religion and occupation.
Patient who will ready to give written consent.
|
|
| ExclusionCriteria |
| Details |
Subjects are excluded from this study if any 1 or more of the following criteria is met
Subject has clinically atypical warts on the trunk or extremities.
Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
Subject has perienguinal, subenguinal, genital, anal, plantar, flat. Known case of Hiv ,Hepatites B.
Patient suffer from current skin disease known case of psoriasis, atopic dermatitis, eczema, sun damage, sunburn, excessive hair, open wounds.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in redness,edema and pain |
07 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total reduction in redness,edema,pain & charmkeel
|
21 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2025 |
| 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="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
|
‘Charmakeelatheethi’Charmakeela is the term for
something that resembles a nail (keela) or something bound to the skin (charma)[2].Since
ancient times, charmakeela has been a common ailment that requires more
individualized care for psychological reasons. Among the kshudraroga that
acharya Susrutha mentions is Charmakeela.
"Paka" (preparation) and "vidhi" (application) are
associated with "Kshara." Caustic alkali is preferable to other
sharper and auxiliary instruments because it can perform excision, incision,
and scarification; it also relieves three doshas and has specialized uses. All
three of the parasurgical techniques—Agni (cauterization), Kshara (caustic
alkali), and Jalauka (leeches)—have significance. Kshara remains the leader
despite Agni and Jalauka’s incapacity to execute some surgeries like incision
and excisionWarts are benign skin growths that have been present in human
society from ancient times |