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CTRI Number  CTRI/2023/02/049952 [Registered on: 22/02/2023] Trial Registered Prospectively
Last Modified On: 20/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda
Other (Specify) [Curative]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of Heelpain by Agnikarma and Vidhya Agnikarma 
Scientific Title of Study   Open Labeled Randomized controlled Trial TO Compare The Effect Of Agnikarma And Viddha-Agnikarma In Vatakantak (Plantar Fasciitis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Subhashrao Suryawanshi 
Designation  PG Scholar 
Affiliation  Shri Ayurved Mahavidyalaya,Nagpur 
Address  OPD no 7, Shalyatantra department, Pakswasa Samanvay Rugnalaya , Shri Ayurved Mahavidyalaya, Hanuman Nagar, Dhanwantari Marga, Nagpur
Hanuman Nagar, Nagpur, Maharashtra, India. 440024
Nagpur
MAHARASHTRA
440024
India 
Phone  7743842877  
Fax    
Email  anjalisuryawanshi8394@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandesh Khobragade 
Designation  Associate Professor 
Affiliation  Shri Ayurved Mahavidyalya, Nagpur 
Address  OPD no 7, Shalyatantra department, Pakswasa Samanvay Rugnalaya , Shri Ayurved Mahavidyalaya, Hanuman Nagar, Dhanwantari Marga, Nagpur
Hanuman Nagar, Nagpur, Maharashtra, India.440024
Nagpur
MAHARASHTRA
440024
India 
Phone  9987014379  
Fax    
Email  drsandesh1128@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjali Subhashrao Suryawanshi 
Designation  PG Scholar 
Affiliation  Shri Ayurved Mahavidyalaya, Nagpur 
Address  OPD no 7, Shalyatantra department, Pakswasa Samanvay Rugnalaya , Shri Ayurved Mahavidyalaya, Hanuman Nagar, Dhanwantari Marga, Nagpur
Hanuman Nagar, Nagpur, Maharashtra, India 440024
Nagpur
MAHARASHTRA
440024
India 
Phone  7743842877  
Fax    
Email  anjalisuryawanshi8394@gmail.com  
 
Source of Monetary or Material Support  
Shri Ayurved Mahavidyalay, Nagpur 
 
Primary Sponsor  
Name  Dr Anjali Subhashrao Suryawanshi 
Address  OPD no 7, Shalyatantra department, Pakswasa Samanvay Rugnalaya , Shri Ayurved Mahavidyalaya, Hanuman Nagar, Dhanwantari Marga, Nagpur 
Type of Sponsor  Other [self] 
 
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 Anjali Subhashrao Suryawanshi  Shri Ayurved Mahavidyalaya, Nagpur  OPD no 7, Shalyatantra department, Pakswasa Samanvay Rugnalaya , Shri Ayurved Mahavidyalaya, Hanuman Nagar, Dhanwantari Marga, Nagpur
Nagpur
MAHARASHTRA 		 7743842877

anjalisuryawanshi8394@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Shri Ayurved Mahavidyalaya, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M722||Plantar fascial fibromatosis. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Dr R B Gogate, Viddha and agnikarma Chikitsa book, Vaidyamitra publication, Pune, Procedure details: Group A of 27 patient having vatakantaka will be treated by viddha-agnikarma . After 1st sitting follow up on 4 th, 7th day will be taken and After 2nd sitting follow up will be taken on 4th, 7th day for 18 months )
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushrut Samhita, Procedure details: Group B of 27 patients having vatakantaka will be treated by Agnikarma. After 1st sitting follow up will be taken on 4th, 7th day. After 2 nd sitting, follow up will be taken on 4th, 7th day for 18 months.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed Patients of Vatakantaka (plantar fasciitis)
2. Age group more than 18 years.
3. Selection will be irrespective of gender, religion and socio-economic status
 
 
ExclusionCriteria 
Details  1. Uncontrolled systemic diseases like diabetes mellitus, hypertension.
2. Fracture of calcaneum.
3. Other pathologies like osteomyelitis of calcaneum.
4. Immuno-compromised Patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Viddha-Agnikarma in Vatakantaka in pain management and compare its effect with Agnikarma.(Plantar Fasciitis)  follow up on 4th , 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
To study other adverse effect of Viddha-Agnikarma  follow up on 4th, 7th day 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   23/02/2023 
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   Not yet done 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study will be carried out in concerned institute in Maharashtra state of India on study population. This research work aim to study the effect of Viddha-Agnikarma in the treatment of Vatakantaka in comparison with Agnikarma. Total 54 patients fulfilling inclusion criteria will be included in the study and will be randomly divided into two groups i.e group A and group B each containing 27 subjects. Group A will be experimental group where patient will be given Viddha-Agnikarma treatment. Group B will be control group where patients will be given Agnikarma treatment. Patients will be observed on 4th and 7 th day and all the findings will be recorded in case record form. At the end of trial, collected data will be analyzed with the help of authorized statistician and result will be drawn accordingly. 
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