| CTRI Number |
CTRI/2023/02/049606 [Registered on: 10/02/2023] Trial Registered Prospectively |
| Last Modified On: |
08/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of Agnikarma (heat therapy) and Sira-Vyadha (Blood letting) in the management of vatakantaka (Heel pain) |
|
Scientific Title of Study
|
A comparative study of Agnikarma and Sira-Vyadha in the management of vatakantaka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pardeep Sharma |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College |
| Address |
Room no. 106 PG Department of Shalya Tantra
Shri Krishna Govt. Ayurvedic College Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9466751843 |
| Fax |
|
| Email |
ps60339@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Khurana |
| Designation |
Professor |
| Affiliation |
Shri Krishna Govt. Ayurvedic College |
| Address |
Shri Krishna Govt. Ayurvedic College Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9416337325 |
| Fax |
|
| Email |
dr.devendrakhurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pardeep Sharma |
| Designation |
PG Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College |
| Address |
Room no. 106 PG Department of Shalya Tantra
Shri Krishna Govt. Ayurvedic College Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9466751843 |
| Fax |
|
| Email |
ps60339@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna AYUSH University sector 8 umri road Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Shri Krishna AYUSH University |
| Address |
Umri Road Sector 8 Kurukshetra |
| 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 Pardeep Sharma |
Shri Krishna Govt Ayurvedic College and Hospital |
Room No. 106, PG Department of Shalya Tantra
Shri Krishna Govt. Ayurvedic College
Kurukshetra
Kurukshetra
HARYANA |
9466751843
ps60339@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University research Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M722||Plantar fascial fibromatosis. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta samhita Sutra Sthan 12/10, Procedure details: Agni Karma with Panchdhatu Shalaka will be done at most tender points on 0,7 & 14th day)
| | 2 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Sushruta Samhita Chikitsa Sthan 5/23, Procedure details: Siravyadha will be done at 2 angula above Kshipra Marma of affected foot on 0,7 & 14th day)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with pratyatmalakshanas of vatakantakai.e, pain in the heel region
with or without local swelling, stiffness and tenderness |
|
| ExclusionCriteria |
| Details |
Calcaneal stress fracture, RA, gout, neoplastic condition, nerve entrapment syndromes.
Subjects with impaired circulation to lower extremities.
Subjects with referred pain due to sciatica & other neurological disorders.
Corticosteroid injections to heel, preceding 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The improvement in the patient is assessed mainly on the basis of relief in the
cardinal signs & symptoms of the disease and will be scored |
Baseline, 1 week, 2 week & 3 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The improvement in the patient is assessed mainly on the basis of relief in the
|
Baseline, 1 week, 2 week & 3 week |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/02/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ayurveda is the science of life since immemorial time and has been
showing the ideal way of living which promises a disease free, healthy and long
life. ShalyaTantra is prime branch which is rich in all aspect of surgical
concepts.
In ayurveda, Vatakantaka is basically a Vyadhiof vitiated VataDoshas
and comes under Vatavyadhi. AcharyaSushruta has mentioned the disease in
Nidansthana1
. He stated that, improper pattern of walking, uneven pathways or
excessive walking is the cause of disease. Same pathology is mentioned by
AcharyaVagbhata at Vagbhatnidandhyaya2
From above all views of ayurvedic
texts, we can conclude that pain over heel area is the main symptom of disease.
Ayurveda has mentioned the treatment of Vatakantaka under
iVatavyadhchikitsa. Both Bahya and AbhyantarChikitsahas are to be done to
treat it, which include local Snehan, Upanaha, Agnikarma, ,Bandhan,
Suchikarma (Viddhakarma) and AbhyantartahaErandsnehapaana. With the
help of this treatment, we can correct the vitiation of Vata and can give relief to
the patient3
. |