| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M05-M14||Inflammatory polyarthropathies. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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. |