| CTRI Number |
CTRI/2025/02/080513 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Ayurvedic Thermal Procedure By Swarna And Panchdhatu Rod In Treatment Of Heel Pain Management. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Agnikarma With Swarna Shalaka And Panchdhatu Shalaka In The Management Of Vatkantaka. |
| 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 Sarita Thakre |
| Designation |
PG Scholar |
| Affiliation |
NPA Govt ayurvedic medical college Raipur CG 492010 |
| Address |
Department of Shalya Tantra
NPA Govt ayurvedic medical
college Raipur CG
492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9893810790 |
| Fax |
|
| Email |
27saritathakre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dheeraj Singh Baghel |
| Designation |
Reader Deparment Of Shalya Tantra |
| Affiliation |
NPA Govt ayurvedic medical college Raipur CG 492010 |
| Address |
Department Of Shalya Tantra
NPA Govt Ayurveda Medical
College Raipur CG
492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9039764601 |
| Fax |
|
| Email |
dr.bgheldheeraj25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balendra Singh |
| Designation |
Professor And HOD Department Of Shalya Tantra |
| Affiliation |
NPA Govt ayurvedic medical college Raipur CG 492010 |
| Address |
Department Of Shalya Tantra
NPA Govt Ayurvedic Medical College Raipur CG
492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9039180335 |
| Fax |
|
| Email |
drbalendrasingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri NPA Govt Ayurveda College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Office of Principal Shri NPA Govt Ayurveda College Raipur Chhattisgarh |
| Address |
Department of Shalya Tantra Shri NPA Govt Ayurveda College Raipur Chhattisgarh |
| Type of Sponsor |
Government 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 Sarita Thakre |
Shri Khudadad Dungaji Ayurveda Hospital Raipur Chhattisgarh |
OPD no 15 of Shalya Tantra Department
Raipur Chhattisgarh
Raipur
CHHATTISGARH |
9893810790
27saritathakre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Principal Shri NPA Govt Ayurveda College Raipur Chhattisgarh 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M773||Calcaneal spur. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrut chikitsa 4, Procedure details: Agnikarma Shalaka (Swarna & Panchdhatu Shalaka) will be red hot in smoke- free
fire instrument (Gas Stove).
At the site of most tender point Bindu type Agnikarma done till Samayk Dagdha
symptoms appear.
1/2 Angul (approx.1cm)space between two Samyak Dagdha will be maintain.
After each Samyaka Dagdha pulp/gel of Ghrita Kumari will be apply on Vrana to get
rid of instant burning sensation.
Duration - 28 days
Frequency - procedure will be done with the interval of 7 days.
1st-7th-14th-21th-28th)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with the symptoms of Vatkantaka |
|
| ExclusionCriteria |
| Details |
Severe Anaemic patient
Malnourish patient as per age height of weight proportion
Patient with septicaemia
The patient suffering from systemic disease such as osteomyelitis calcaneal tumour and anatomical deformity below ankle
Uncontrolled DM and HTN
Pregnancy and lactating mother
HIV and HBsAg Infection |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Observe The Effect of Agnikarma in The Management of Vatakantak. |
Procedure Will Be Apply For Heel Pain Management For 1 Month At 7 Days Interval And Follow Up Will Be Twice in a Month For 15 Days Interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Relieving Other Associated Symptoms Like Pain And Restricted Movements Which Affects Daily Routine Activities |
Procedure Will Be Apply For Heel Pain Management For 1 Month At 7 Days Interval And Follow Up Will Be Twice in a Month For 15 Days Interval |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction - Pain is the one symptom which affect our daily routine activities and the quality of life. pain and heel is one of among such pain which causes difficulty in walking and it disturbs daily routines. In ayurveda this symptoms co-relate with Vatakantaka. Vatakantaka is basically a vyadhi of vitiated Vata dosha and under Vatavyadhi. It causes severe Heel pain. According to Acharya Sushrut Vatakantaka mentioned under the heading of Vatavyadhi and the etiology is keeping the foot of uneven surface that causes vata gets aggravated and localised in Khuddak pradesh. Vatakantaka is a Snayu Asthi Sandhi Ashrit vyadhi and a painful condition. According to Sushrut Chikitsa 4/8 Agnikarma is indicated as one of the best treatment of the pain in this condition.
Need of the Study - Less chance of Recurrence after Agnikarma. It is a good parasurgical method for pain management and Cost effective method. Performed at OPD Level and No need of hospitalization.
Type of Study - Prospective Open Non randomized Interventional Comparative Clinical Study
|