| CTRI Number |
CTRI/2024/09/073742 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the effect of viddha agnikarma in the management of calcaneal spur (calcaneal spur). |
|
Scientific Title of Study
|
An open label randomized controlled clinical study to evaluate the effect of Viddha Agnikarma in the management of Vatakantaka vis a vis calcaneal spur |
| 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 Punith C |
| Designation |
Pg scholar |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
JSS Ayurveda medical college and hospital
Opd no.10,department of shalya tantra
41e Lalitadripura road alanahalli Mysuru-570028
Mysore
KARNATAKA
570028
India |
| Phone |
8792536788 |
| Fax |
|
| Email |
punithchennakeshav4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddayya Aradhyamath |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
JSS Ayurveda medical college and hospital
Opd no.10,department of shalya tantra
41e Lalitadripura road alanahalli Mysuru-570028
Mysore
KARNATAKA
570028
India |
| Phone |
9449972788 |
| Fax |
|
| Email |
drsiddesharadhyamath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punith C |
| Designation |
Pg scholar |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
JSS Ayurveda medical college and hospital
Opd no.10,department of shalya tantra
41e Lalitadripura road alanahalli Mysuru-570028
Mysore
KARNATAKA
570028
India |
| Phone |
8792536788 |
| Fax |
|
| Email |
punithchennakeshav4@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurvedic Medical College and Hospital, 41/E, Lalithadripura road, Mysuru, 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Punith C |
| Address |
JSS Ayurveda medical college and hospital
Opd no.10 department of shalya tantra
41e Lalitadripura road alanahalli Mysuru 570028 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DRSIDDAYYA ARADHYAMATH |
JSS Ayurveda College and Hospital |
ROOM NO.10, DEPARTMENT OF PG AND PhD STUDIES IN SHALYA TANTRA, JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL, LALITHADRIPURA ROAD, MYSURU
Mysore
KARNATAKA |
9449972788
drsiddesharadhyamath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS AYURVEDA MEDICAL COLLEGE |
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, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Chakradutta, vatakantaka chikitsa, 48th sloka, Procedure details: Subjects will be made to lie in prone position.
The sterile Acupuncture needles will be pricked at the depth of 5mm-10mm at marked tender points.
Indifferent electrode (Cautery Patient Plate) contact with the skin of the subject.
The active electrode will be gently touch to the needles.
After that the needles are removed. Like wise 3 sittings will be done with 7 days gap.
)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Susruta samhita, sutra sthana, 12th chapter, Procedure details: After marking the site of maximum tenderness, Binduroopi Agnikarma with Agnitapta Panchaloha Shalaka will be done over the marked sites. Like wise 3 sittings will be done with 7 days gap.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with the signs and symptoms of Vatakantaka pain and stiffness.
Age group of 18-60 years irrespective of gender, religion and occupation.
Controlled DM, (where HbA1c is less than 6.5)and Hypertension.
|
|
| ExclusionCriteria |
| Details |
Local infection of foot, Osteoporosis, Osteomyelitis, Achilles tendinitis, CA of the bone. Diabetic foot and foot deformities like Talipes Calcaneus, Cavus, Varus, Valgus, Calcaneovarus
Corn, tropical ulcer, open wound and other allergic skin conditions in foot.
Fracture of calcaneus and ankle joint
Patients diagnosed as HIV and HBsAg
Pregnant and lactating women
Other systemic and metabolic disorders like uncontrolled Diabetes mellitus, Hypertension , TB.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disappearance of pain |
21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disappearance of tenderness |
28th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
16/09/2024 |
| 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="6"
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
is described under Vataja Vyadhi.The main Lakshana of
Vatakantaka is pricking pain felt due to vitiated Vata in
Calcaneal bone. Due to exertion & walking on uneven surface, Usage of hard
foot wears leads to constant pressure in heel region, Calcium deposition occurs
beneath this bone and if the pressure continues, the deposition takes the shape
of spur, this leads to aggravation of Vata causing pain.
It
is estimated that Incidence of calcaneal spur in Indian population with heel
pain is 59%, Most common age group affected is 40-50years.
Vatakantaka
clinically can be co-related to calcaneum spur or heel spur, it is a
pointed bony outgrowth of the calcaneal bone. It is attributed to chronic local
inflammation at the insertion of soft-tissue tendons or fascia. Heel
spurs are frequently associated with inflammation of the Achilles tendon and
cause tenderness and pain.
Agnikarma
is one among the para surgical procedure indicated for pain management. It is
superior, the diseases treated by Agnikarma is said to have no
recurrence5, it is a unique procedure because of its simple
technique yet optimum result. Hence it is extensively practiced in painful
conditions like Gridrasi, Avabhahuka and Vatakantaka.
The
disease which are situated over Twak, Mamsa, Snayu, Asthi etc., are
treated with Agnikarma by using different Dahanopakaranas5.
The
author Chakradatta has added Suchi is also one among the Dahanopakaranas
6.
Bindu
Roopi Agnikarma with Panchaloha Shalaka is being extensively
done.
But
as it involves burning of the skin & superficial tissues there may be
discomfort to the patient and also skin
scarring. The uniformity of heat is not maintained throughout the procedure7.
Viddha
Agnikarma is selected because it goes deep into the fascia and spreads the
heat uniformly, and cosmetically good as there will be no scarring of tissues.
|