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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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.)
2Comparator Arm (Non Ayurveda)-tens therepyelectrodes 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

 
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