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CTRI Number  CTRI/2025/05/086542 [Registered on: 07/05/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Healing Heel Pain: A Study on Ancient and Modern Treatments 
Scientific Title of Study   A clinical study to evaluate the efficacy of Agni Karma and Platelet Rich Plasma in the management of Vata Kantaka w.s.r. to Plantar Fasciitis. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Anil Kumar Sharma 
Designation  professor  
Affiliation  R.G.G.P.G. Ayurvedic College and Hospital Paprola,Kangra 
Address  Room No. 206,Department of Shalya Tantra, Anatomy Block R.G.G.P.G Ayurvedic college and hospital Paprola Kangra OPD No.105,Department of Shalya Tantra,RAH Paprola, Kangra H.P 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9805056393  
Fax    
Email  dranilpaprola@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Anil Kumar Sharma 
Designation  professor  
Affiliation  R.G.G.P.G. Ayurvedic College and Hospital Paprola,Kangra 
Address  Room No. 206,Department of Shalya Tantra, Anatomy Block R.G.G.P.G Ayurvedic college and hospital Paprola Kangra OPD No.105,Department of Shalya Tantra,RAH Paprola, Kangra H.P 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9805056393  
Fax    
Email  dranilpaprola@gmail.com  
 
Details of Contact Person
Public Query  
Name  vikas 
Designation  PG Scholar 
Affiliation  R.G.G.P.G. Ayurvedic College and Hospital Paprola,Kangra 
Address  R.G.G.P.G Ayurvedic college and hospital Paprola Kangra Himachal pradesh 176115 India

Kangra
HIMACHAL PRADESH
176115
India 
Phone  9729603843  
Fax    
Email  vickyrao.0146@gmail.com  
 
Source of Monetary or Material Support  
department of Rog Nidan(Pathology), Rajiv Gandhi Goverment Post Graduate Ayurvedic college andHospital Paprola teh. Baijnath distt Kangra H.P.176115 
 
Primary Sponsor  
Name  Principal R.G.G.P.G Ayurvedic College and hospital Paprola 
Address  Rajiv Gandhi Goverment Post Graduate Ayurvedic college andHospital Paprola teh. Baijnath distt Kangra H.P.176115 
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 Vikas  R.G.G.P.G.Ayurvedic college and hospital Paprola H.P.  Room no 321 OPD/IPD of Shalya tantra department R.G.G.P.G.Ayurvedic college and hospital Paprola teh baijnath distt kangra H.P.176115 Kangra HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH 		 9729603843

vickyrao.0146@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethics Commitee(Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital Paprola Kangra Himachal Pradesh 176115  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, (3) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: VATAKANTAKAM, (4) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: sushrut sutra 12, Procedure details: will be done with panchdhatu shalaka 3 sittings with interval of 7 days)
Intervention  Agnikarma   Agnikarm with panchdhaatu shalaka total 3 sitting in interval of 7 days  
Comparator Agent  PRP  platelet rich plasma total 2 sitting with dose 2 ml at most tender site with interval of 15 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients diagnosed with planter fasciitis 
 
ExclusionCriteria 
Details  1)Pregnant women.
2)Patient having tuberculosis,uncontrolled diabetes mellitus,hypertension, Rheumatoid arthritis.
3)HBsAG ,ICTC positive patients. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Agnikarma and Platelet rich plasma in the management of Vata Kantaka specially pain relieve or not on patient response   Total time period of study 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To asses the improvement in quality of life of patient after treatment.  30 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 2/ Phase 3 
Date of First Enrollment (India)   22/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  22/05/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="30" 
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   Study will be carried out in two groups.one group will be treated with agnikarma procedure and second group will be treated with protein rich plasma .Compartive efficacy of both the groups will be analysed at the end of  trail. 
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