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CTRI Number  CTRI/2025/08/093649 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 25/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of aganikarma with pippali and lauha salaka in the management of vatakantaka (heel pain) 
Scientific Title of Study   Comparative clinical study to evaluate the therapeutic effect of aganikarma with pippali and lauha Shalaka in the management of vatakantaka (heel pain) 
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 PRAGYA SAHU 
Designation  PG Scholar 
Affiliation  Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road 
Address  OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road Bulandshahar UTTAR PRADESH 203131 India

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9455155889  
Fax    
Email  drpragya2016@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arjun Anil  
Designation  Associate Professor 
Affiliation  Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road 
Address  OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road Bulandshahar UTTAR PRADESH 203131 India

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  6360340886  
Fax    
Email  dr.arjunanil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR PRAGYA SAHU 
Designation  PG Scholar 
Affiliation  Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road 
Address  OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road Bulandshahar UTTAR PRADESH 203131 India

Bulandshahar
UTTAR PRADESH
203131
India 
Phone  9455155889  
Fax    
Email  drpragya2016@gmail.com  
 
Source of Monetary or Material Support  
Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya And PLRD Hospital Khurja Bulandshahar Uttar Pradesh 
 
Primary Sponsor  
Name  DR PRAGYA SAHU 
Address  Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road Bulandshar utter pradesh 203131 
Type of Sponsor  Private 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 PRAGYA SAHU  Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar GT road  OPD Number 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Dharpa Khurja Bulandshahar GT Road Bulandshahar UTTAR PRADESH
Bulandshahar
UTTAR PRADESH 
9455155889

drpragya2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Vaidya Yagya Dutt Sharma Ayurved Mahavidhalaya Khurja district Bulandshahar Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M05-M14||Inflammatory polyarthropathies. Ayurveda Condition: VATAKANTAKAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushurt Sutrasthan, Procedure details: (Procedure Reference: , Procedure details: Agnikarma with pippli & lauhsalakha in the management of vatkantaka. ones in 7 days.))
 
Inclusion Criteria  
Age From  20.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  1. adult patient is 20 to 60 years who have been clinically diagnosed with varkantaka(heels pain) based on comprehensive physically examination.
2. Participants who are capable of providing informed consent and are willing to adhere in the study protocol, including all treatment sessions and follow up visit. 
 
ExclusionCriteria 
Details  1.Patients who are under gone similar ayurvedic or allopathic treatments for vatkantaka which could impact the efficacy of the interventions under investigation.
2. Major systematic disorders like RA .
3. Pregnancy and malignancy.
4. Uncontrolled diabetes ,known HIV , HBsAg positive patients are also excluded. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the therapeutic effect of agnikarma with pippli and lauha shalakha in the managment of vatkantaka(heels pain)  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To introduce the best & cost effective modality of treatment
decrease risk of recurrence &
fasten the recovery.
 
After analysing all parameters the result will be assessed on the basis of symptomatic relief . 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/09/2025 
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="0"
Months="8"
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  

Vatakantaka, described in Ayurvedic literature as a Vatavyadhi disease caused by the vitiation of Vata dosha, is characterized by severe, thorn-like pain in the foot due to Vata aggravation in the ankle region  This pain can significantly impair daily activities, making movement painful and difficult. The condition is well-documented by Sushruta, the father of surgery in Ayurveda, who attributes its onset to uneven foot placement, leading to Vata dosha’s localization in the ankle joint. Other Ayurvedic scholars, including Acharya Vaghbata  and Madhav  also associate Vatakantaka with excessive strain on the foot, such as walking on uneven surfaces or prolonged standing.

In modern medicine, Vatakantaka is often compared to Plantar Fasciitis, but it also represents a broader range of clinical conditions where heel pain is the primary symptom. These conditions include calcaneal spurs, Achilles tendinitis, bursitis, fat pad atrophy, tarsal tunnel syndrome, and stress fractures. Each of these conditions presents with varying degrees of discomfort, often linked to inflammation, overuse, or degeneration of the soft tissues and structures around the heel.

In conditions like Plantar Fasciitis, the pain stems from inflammation of the plantar fascia, a band of tissue that connects the heel bone to the toes. Calcaneal spurs involve bony growths on the underside of the heel, often associated with chronic plantar fasciitis. Achilles tendinitis results from inflammation of the Achilles tendon, and bursitis involves inflammation of the bursae, the small sacs of fluid that cushion the heel. Fat pad atrophy occurs when the natural cushioning beneath the heel bone deteriorates, and tarsal tunnel syndrome is caused by nerve compression. Finally, stress fractures result from overuse or repetitive impact, leading to small cracks in the heel bone.

Conventional treatments for these conditions—such as physiotherapy, stretching exercises, custom orthotics, NSAIDs, steroid injections, and even surgical interventions often provide only temporary relief. These approaches largely focus on reducing inflammation and pain but may not address the root causes of heel pain or promote long-term healing. Recurrence is common, especially for conditions like plantar fasciitis, where structural or biomechanical issues persist despite treatment.


 
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