| CTRI Number |
CTRI/2024/06/068949 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management in Charmakeela (Skin Warts) |
|
Scientific Title of Study
|
An Open Labelled Clinical Study To Evaluate The Effect Of Intralesion
Injection Of Apamarga Kshara In Charmakeela W.S.R To Cutaneous 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 Harshitha M Rao |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara college of ayurveda,kuthpady,udupi . |
| Address |
Department of PG studies in Shalya Tantra Sri Dharmasthala
Manjunatheswara college of Ayurveda and Hospital Kuthpady Udupi
Karnataka
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9740262379 |
| Fax |
|
| Email |
harshitha.madhav.rao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara college of ayurveda,kuthpady,udupi . |
| Address |
Department of PG studies in Shalya Tantra Sri Dharmasthala
Manjunatheswara college of Ayurveda and Hospital Kuthpady Udupi
Karnataka
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9844838773 |
| Fax |
|
| Email |
kamathsahanak@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara college of ayurveda,kuthpady,udupi . |
| Address |
Department of PG studies in Shalya Tantra Sri Dharmasthala
Manjunatheswara college of Ayurveda and Hospital Kuthpady Udupi
Karnataka
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9844838773 |
| Fax |
|
| Email |
kamathsahanak@ymail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Kuthpady Udupi
Karnataka 574118
|
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheswara College Of Ayurveda |
| Address |
SDM COLLEGE OF AYURVEDA
KUTHPADY UDUPI 574118 |
| Type of Sponsor |
Private medical college |
|
|
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 Harshitha M Rao |
Sri Dharmasthala Manjunatheswara Ayurveda Hospital. |
OPD No 5 and OPERATION Theatre
Department of
Shalyatantra
Kuthpady Udupi
574118
Udupi
KARNATAKA
Udupi
KARNATAKA |
9740262379
harshitha.madhav.rao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM College of Ayurveda kuthpady, Udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B079||Viral wart, unspecified. Ayurveda Condition: CARMAKILAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Apamarga , Reference: Susruta samhita , Route: Topical, Dosage Form: Kshara , Dose: 2(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Used in Charmakeela via Intra-Lesion Injection | | 2 | Intervention Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta samhita SutraSthana 11 Chapter, Procedure details: Pre operative
Required investigations (Hb%, TC DC, BTCT, HIV HBsAg, RBS)
Written Informed consent
Operative
Painting and Drapping of the site.
Apamarga Kshara diluted with Distilled Water taken in Insulin
syringe dose depending on the size of the wart
Injected into the Base of the Wart
Post operative
Obeserve for 30 minutes for any side effects
Maintain hygiene over the site)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Cutaneous warts over face, neck region, axilla, hand and feet.
Single Warts with less than or equal to 1cm in size (length, diameter)
|
|
| ExclusionCriteria |
| Details |
1.Patients contraindicated for Ksharakarma as per texts.
2.Anal Warts
3.Genital warts
4.Mucocutaneous Warts
5.Patients with Systemic disease like Uncontrolled diabetes, Hypertension, Cardiac
6.Immune compromised and Sexually Transmitted Disease.
7.Warts greater than 1cm in size (length, diameter)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Find the effect of intralesion injection of Apamarga Kshara based reduction in size and fall off of wart. |
Observing the wart Based on Assessment Parameters
on 0th day
1st day, 3rd 6th 9th 12th and 15th after procedure or till wart fall off |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for wart to shed off |
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
22/06/2024 |
| 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
|
Charmakeela is a disease which causes nail like growth on the skin. Warts are benign epidermal
proliferation caused by infection with Human Papilloma Virus. It is common in children and adult with a high
prevalence of 3-13% in general population.[1] It causes discomfort and hinders confidence, spreads by
autoinoculation or direct contact.
Warts Treatment modalities such as Topical applications of Salicylic Acid and Lactic Acid,
Intralesional Bleomycin or Interferon Injections, Cryotherapy require time to achieve response. Laser therapy,
Surgery- excision, curettage, Electro-cautery have post interventional- local irritation, scarring and pain.[2]
Ayurveda mentions Kshara karma as one of the chikitsa for Charmakeela.[3] Kshara karma is
considered superior among Shastra and Anushastra due to Chedana, Bhedana, Lekhana, Tridoshaghna,
Ropana and Vilayana Karma.
[4] Apamarga, one among the Kshara Dravya has properties of Kaphavataghna,
Arshoghna, Kustapaha. Clinical studies on warts using different Kshara intralesion injection have given a
single sitting response, had least and easy post interventional management and was cost effective. Animal
study of Apamarga Kshara have reported it to be safe at different dose levels and the authors concluded that
the formulations were safe.[5] Hence, this study is intended to evaluate the effect of novel technique of
intralesion injection using Apamarga Kshara on warts.
|