CTRI Number |
CTRI/2025/06/089666 [Registered on: 27/06/2025] Trial Registered Prospectively |
Last Modified On: |
26/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda Other (Specify) [Needle 26 Gauge and Cautery ] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A study to know the effect of viddha agnikarma for the treatment of pain in sciatica |
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDDHA AGNIKARMA WITH TENS THERAPY IN THE PAIN MANAGEMENT OF GRIDHRASI (SCIATICA) |
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 Gurudevi Biradar |
Designation |
PG Scholar |
Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital |
Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Shalya Tantra Koppal
Koppal KARNATAKA 583231 India |
Phone |
9964275001 |
Fax |
|
Email |
gurudevibiradar123@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mahantesh M Salimath |
Designation |
Professor |
Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital |
Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Shalya Tantra Koppal
Koppal KARNATAKA 583231 India |
Phone |
9845010950 |
Fax |
|
Email |
dr_mahantesh@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mahantesh M Salimath |
Designation |
Professor |
Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital |
Address |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital Department of Shalya Tantra Koppal
KARNATAKA 583231 India |
Phone |
9845010950 |
Fax |
|
Email |
dr_mahantesh@yahoo.com |
|
Source of Monetary or Material Support
|
room no.16 department of pg studies in shalya tantra, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital, Koppal, karnataka, INDIA PIN-583231 |
|
Primary Sponsor
|
Name |
Dr Gurudevi Biradar |
Address |
room no.16 department of pg studies in shalya tantra, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital, Koppal, karnataka, INDIA PIN-583231 |
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 |
Dr Gurudevi Biradar |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital,koppal |
room no.16 department of shalya tantra, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital, Koppal,karnataka, INDIA PIN-583231 Koppal KARNATAKA |
9964275001
gurudevibiradar123@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: SUSHRUT SAMHITA, Procedure details: AFTER PALPATING THE TENDER POINTS WERE NOTED.USING A 26 GAUGE NEEDLE THE THOSE POINTS WILL BE PRICKED AND USING CAUTERY AGNIKARMA WILL BE DONE IN THE INTERVAL OF 5 DAYS AND 4 SETTINGS FOR TOTAL 21 DAYS.)
| 2 | Comparator Arm (Non Ayurveda) | | - | tens therepy | electrodes are placed in the trigger points with frequency of 1hz to 4hz
intensity of 30 Ma to 60 Ma and pulse width 150 microseconds to 250 microseconds
procedure done for 15 minutes for a duration of 21 days |
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Patient of either gender diagnosed with case of Gridhrasi.
Age between 20-50 years.
SLR- 30-70 degree
Intervertebral disc bulge.
|
|
ExclusionCriteria |
Details |
Diagnosed case of Bening or malignant tumor of the spine.
Diagnosed case of Pott’s disease.
Diagnosed case of Spinal deformity.
Diagnosed case of Uncontrolled diabetes mellitus.
Cardiovascular disease.
Pregnancy.
Post traumatic injury leading to sciatica.
Serology positive patient
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Viddha Agnikarama is more effective than TENS Therapy in the pain management in Gridhrasi. |
42 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Stiffness reduction
pain reduction |
42 days |
|
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)
|
10/07/2025 |
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="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
|
Gridhrasi is one among the Vata Vyadhi1 which affects Kati, Prusta, Uru, Janu, Janga and Pada. Stambha(stiffness), Ruk(pain), Toda (pricking sensation) and Spandana (tingling sensation) are the signs and symptoms of Gridhrasi.2 The clinical features of Gridhrasi can be correlated with that of sciatica. Back ache is a global and most common problem in working population. Back ache is the most common cause of disability in the patient under age group 45years of age.3 Life time incidence of low back pain is said to be 50-70%. Sciatica is one of the most common conditions where repeated episodes of low back pain precede by month or year. Incidence of having sciatica is seen in 40% of cases.4 Constant pain is felt along the distribution of sciatic nerve root and often due to disc protrusion. Symptoms includes pain in the lumbar region radiating down to buttock, thigh, calf and posterior-lateral aspects of foot. 5 In modern acute pain management is by NSAID’S, analgesics and local anesthetics and corticosteroids, early mobilization and other physiotherapy techniques and surgical intervention.5 Trans cutaneous electrical nerve stimulation that primarily aims to provide a degree of pain relief by exciting sensory nerves6,7 In Ayurveda various treatment modalities are used for treatment of Gridhrasi which includes Sneha, Sweda, Abyanga, Virechana, Basti, Siravyadha and Agnikarma.8 Various Dahanopakarans such as Pippali, Ajashakrit, Godantha, Shara, Shalaka, Jambhvostha, Madhu, Guda 9and various other type of metals, in which Suchi is one.10Among these Agnikarma procedure seems to be more effective which provides timely relief, hence here an attempt is made to treat pain using Vidddha Agnikarma |