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CTRI Number  CTRI/2024/02/062468 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 02/02/2024
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   A clinical trial to study the effect of two drug, erand patranal kshar and salicylic acid on patients having wart. 
Scientific Title of Study   Open Randomized Controlled Trial On Erand Patranal Kshar On Mashak With Special Reference to 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  Akash vijay chavhan 
Designation  PG 2nd year 
Affiliation  Government ayurved college and hospital, nagpur 
Address  Department of shalyatantra,OPD No.3,government ayurved college and hospital,Sakkardara square, nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9604593694  
Fax    
Email  akashchavhan862@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Subhash raut 
Designation  Dean 
Affiliation  Government ayurved college and hospital, nagpur 
Address  Department of shalyatantra,OPD No.3,government ayurved college and hospital,Sakkardara square, nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9422108928  
Fax    
Email  drsyraut@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Akash vijay chavhan 
Designation  PG 2nd year 
Affiliation  Government ayurved college and hospital, nagpur 
Address  Department of shalyatantra,OPD No.3,government ayurved college and hospital,Sakkardara square, nagpur

Nagpur
MAHARASHTRA
440024
India 
Phone  9604593694  
Fax    
Email  akashchavhan862@gmail.com  
 
Source of Monetary or Material Support  
Government ayurved college and hospital,nagpur 
 
Primary Sponsor  
Name  Goverment ayurved College and hospital nagpur  
Address  Government ayurved college and hospital,sakkardara square,nagpur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akash vijay chavhan  Government ayurved college and hospital  Department of shalyatantra,OPD No.3,Government ayurved college and hospital,sakkardara square,nagpur
Nagpur
MAHARASHTRA 		 9604593694

akashchavhan862@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government ayurved college ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: MASHAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Erand patranal kshar, Reference: Bhaishajya ratnavali chikitsa 60/36, Route: Topical, Dosage Form: Kshara , Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 1. All the procedure will be done in all aseptic precautions. 2. The wart will be first cleaned with normal saline. 3. Then Erand patranal kshar will be applied and rubbed gently. 4. All other precautions and instructions for avoiding infection will be given to patient. 5. Same procedure of wart dressing will be done daily.
2Comparator Arm (Non Ayurveda)-Salicylic acid1. All the procedures will be done with all aseptic precautions. 2. The what will be cleaned with normal saline. 3. Then salicylic acid ointment 5% will be applied followed by an antiseptic dressing. 4. All other precautions and instructions for avoiding infection will be given to the patient. 5. The same procedure of wart dressing will be done daily.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients willing to participate in the study.
2. Patients having age between 20-70 years will be considered.
3. Patients will be selected irrespective of sex, marital status, educational status.
4. Patients having warts anywhere on the body.
5. Patients having multiple warts.
6. Planter warts, periungual warts, filiform warts, genital warts, common warts.
7. Patients with controlled diabetis mellitus (HbA1C <6). 
 
ExclusionCriteria 
Details  1. Mucosal warts.
2. Anaemic patients (Hb <6gm%).
3. Diabetic patients (uncontrolled).
4. Warts present near the periorbital region.
5. Patients with major uncontrolled illness.
6. Non-cooperative patients.
7. Immuno-compromised patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of erand patranal kshar in the management of mashak.  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of salicylic acid in the management of Mashak  7 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   13/02/2024 
Date of Study Completion (India) 16/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [akashchavhan862@gmail.com].

  6. For how long will this data be available start date provided 04-12-2023 and end date provided 04-10-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   After the institutional ethics clearance of the government Ayurved College and Hospital, Nagpur screening of the population will be done from patients in OPD, IPD, and the periphery of our institute in the clinical study of 60 patients of wart (Mashak) will be included. Assessment of the disease will be done according to the signs and symptoms of the wart. During the informed consent process, the subjects will be given enough time to read the Patient information sheet and consent form. Subjects will also be given the freedom to ask the questions and all the questions will be answered. If he or she agrees to participate in the study and if they found fit to be included during screening then he will be recruited into the study. If all inclusion criteria are YES and all exclusion criteria are NO then subjects will be included on the basis of the criteria given. Subjects will then undergo both general and systemic examination.

Medium of dissertation: The study will be written in English and Sanskrit words will be used wherever necessary.

Type of study: A randomized control trial.  Duration of treatment: 7 Days.

Ethical clearance: Clearance from the institutional ethics committee of our institute.

Study Centre: OPD IPD of Shalyatantra and Periphery of Nagpur.

Decoration of study: The study will be carried out for 18 months after approval of the synopsis

Treatment details: 


 GroupGroup A (Trial group)Group B (Control group)
 Treatment Erand patranal kshir Salicylic acid
 No. of patients 3030 
 Route of administration Local application (externally)Local application (externally) 
 Dose Once in a day Once in a day
 Duration 7 days 7 days
 Follow up Every alternate day up to 1 week every alternate day Up to 1 week


 
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