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CTRI Number  CTRI/2023/02/049532 [Registered on: 07/02/2023] Trial Registered Prospectively
Last Modified On: 17/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Viddhagnikarma]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Viddhagnikarma -a simplified agnikarma intervention in pain management of Plantar Fasciitis 
Scientific Title of Study   "A Controlled Open Label Clinical Study To Evaluate The Role Of Viddhagnikarma In Plantar Fasciitis VIS-À-VIS Vatakantaka 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Padma 
Designation  PhD Scholar 
Affiliation  Government Ayurveda Medical College 
Address  Associate Professor, Department of PG Studies in Shalya Tantra, Sri Sri College of Ayurvedic Science and Research,21st KM, Kanakapura Road,Udayapura Post, Bengaluru,Karnataka
Department of PG Studies and PhD Studies in Shalya Tantra, Dhanvantari Road, Bengaluru,560009
Bangalore
KARNATAKA
560082
India 
Phone  9900410580  
Fax    
Email  drpadmabhats@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srinivas Masalekar 
Designation  Professor  
Affiliation  Government Ayurveda Medical College 
Address  Government Ayurveda Medical College, Department of PG Studies and PhD Studies in Shalya Tantra, Dhanvantari Road,Bengaluru
Department of PG Studies and PhD Studies in Shalya Tantra, Dhanvantari Road, Bengaluru,560009
Bangalore
KARNATAKA
560009
India 
Phone  9886632966  
Fax    
Email  masalekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srinivas Masalekar 
Designation  Professor  
Affiliation  Government Ayurveda Medical College 
Address  Government Ayurveda Medical College, Department of PG Studies and PhD Studies in Shalya Tantra, Dhanvantari Road,Bengaluru
Department of PG Studies and PhD Studies in Shalya Tantra, Dhanvantari Road, Bengaluru,560009

KARNATAKA
560009
India 
Phone  9886632966  
Fax    
Email  masalekar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic Medical College, Bengaluru  
Sri Sri College of ayurvedic science Research Hospital, Kanakapura Road, Bengaluru 
 
Primary Sponsor  
Name  Dr. Padma  
Address  Associate Professor,Department of PG Studies in Shalya Tantra,Sri Sri College of Ayurvedic Science and Research,21st KM,Kanakapura Road,Udayapura Post, Bengaluru,Karnataka 
Type of Sponsor  Other [Self sponsored PhD thesis work] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Padma  Government Ayurveda Medical College  Department of PG Studies and PhD Studies in Shalya Tantra, Dhanvantari Road,Bengaluru,560009
Bangalore
KARNATAKA 		 9900410580

drpadmabhats@gmail.com 
Dr Padma  Sri Sri College of Ayurvedic Science and Research Hospital  Department of PG Studies in Shalya Tantra,21st KM,Kanakapura Road,Udayapura Post, Bengaluru,Karnataka
Bangalore
KARNATAKA 		 9900410580

drpadmabhats@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committtee Government Ayurveda Medical College Bengaluru  Approved 
SRI SRI INSTITUTIONAL ETHICAL COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Viddha agnikarma (Procedure Reference: Sushruta samhita, Procedure details: Under aseptic measures, 23 1/2 hypodermic needles are pierced in affected site and touched with cautery probe for 5 seconds.)
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta samhita , Procedure details: Under aseptic measures, affected area will be applied with hot panchaloha shalaka.The part is then applied with ghee and allowed to take rest)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with features of pain and tenderness in the heel.
 
 
ExclusionCriteria 
Details  Subjects with active inflammatory disease, neoplastic disease and Fracture calcaneum.Subjects with Foreign body in heel like metallic internal fixators for Fracture of calcaneum / ankle fractures.Those having cardiac pace maker.Those contraindicated for agnikarma such as garbhini, durbala.Subjects with systemic disorders like uncontrolled diabetes, IHD.



 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To establish the proposed treatment modality as easy, affordable and better pain management without NSAIDS or surgery.
2.To establish proposed treatment, modality as novel technique in the field of para surgical procedure.
 		 Assessment criteria will be
1.Subjective parameters such as Pain and Foot Function Index
2. Objective parameters such as Tenderness and Windlass Test.
These will be assessed
Before Treatment (BT)- Day 0
During Treatment (DT)- Day 7 After treatment(AT)-Day 14
At Follow up (AF)- 14 days and 28 days after treatment.
 
 
Secondary Outcome  
Outcome  TimePoints 
Prevention of recurrence. Prevention of possible complications. Improve the quality of life.  28th and 42nd day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/12/2023 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   THIS STUDY IS TO EVALUATE THE ROLE OF VIDDHAGNI KARMA IN PLANTAR FASCIITIS VIS-À-VIS VATAKANTAKA "

COMPARISON WITH PANCHALOHA SHALAKA

HYPOTHESIS:

Null hypothesis: 

1.      The role of Viddhagni karma is not significant in plantar fascitis vis a vis Vatakantaka”

2.      The role of Agnikarma with Pancha louha shalaka is not significant in plantar fascitis vis a vis Vatakantaka”

3.      There is no significant difference between the role of Viddhagni karma & agnikarma with panchalouha shalaka in plantar fasciitis vis a vis Vatakantaka

Alternate hypothesis-:                                          

1.      The role of viddhagni karma is significant in plantar fasciitis vis a vis Vatakantaka”

2.      The role of Agnikarma with Pancha louha shalaka is significant in plantar fascitis vis a vis Vatakantaka”

3.      There is significant difference between the role of Viddhagni karma & agnikarma with panchalouha shalaka in plantar fasciitis vis a vis Vatakantaka


 
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