FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078101 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effect of Viddhagnikarma and Agnikarma in the pain management of Sciatica 
Scientific Title of Study   AN OPEN LABEL CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF VIDDHAGNI KARMA IN PAIN MANAGEMENT IN SCIATICA VIS-À-VIS GRIDHRASI. 
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 Shilpa P N 
Designation  PROFESSOR  
Affiliation  Government Ayurvedic Medical College.Bangalore. 
Address  OPD no 10.Department of shalyatantra .Government Ayurveda Medical College Bangalore -560009.

Bangalore
KARNATAKA
560009
India 
Phone  9886792113  
Fax    
Email  drshilpamys@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Duragappa Harijana  
Designation  PhD scholar  
Affiliation  Government Ayurvedic Medical College.Bangalore. 
Address  OPD no 10, Department of shalya tantra. Government Ayurveda Medical College Bangalore -560009.

Bangalore
KARNATAKA
560009
India 
Phone  9886102933  
Fax    
Email  durgeshhabalakatti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Duragappa Harijana  
Designation  PhD scholar  
Affiliation  Government Ayurvedic Medical College.Bangalore. 
Address  OPD no 10.Department of shalyatantra .Government Ayurveda Medical College Bangalore -560009.


KARNATAKA
560009
India 
Phone  9886102933  
Fax    
Email  durgeshhabalakatti@gmail.com  
 
Source of Monetary or Material Support  
OPD no 10.Department of shalyatantra .Government Ayurveda Medical College Bangalore -560009. 
 
Primary Sponsor  
Name  Dr Duragappa Harijana  
Address  Government Ayurveda Medical College Bangalore  
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 Duragappa Harijana  GOVERNMENT AYURVEDA MEDICAL COLLEGE   OPD no 10 Department of shlaya tantra
Bangalore
KARNATAKA 
09886102933

durgeshhabalakatti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT AYURVEDA MEDICAL COLLEGE BANGALORE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Su su 12, Procedure details: Weekly once )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1Selection of subject is done irrespective of gender, religion, occupation, socio economic and educational status.
2Subjects with classical features of Gridhrasi, namely pain over the Sphik (waist), Kati (back), Prishta (thigh), Uru (hip), Janu (knee), Jangha (calf region), extending up to Pada (foot). Stambh (stiffness), Toda (pricking pain), difficulty in walking etc. were included.
3Subjects with features of Sciatica 
 
ExclusionCriteria 
Details  1.Cases of Spondylolisthesis, Sacroiliac arthritis, Herpese simplex infection causing radiating pain.
2.Tuberculoma, or any cyst compressing the nerve root, diabetic neuropathies are excluded,

People of Paittik constitution, where Agnikarma is contraindicated.

Debilated patients, patients below 18 yrs of age, patients affected with multiple wounds, 3.cases with destructed vertebral bodies and fractures of the vertebra were excluded..
4.Subject with any systemic disorder which may interfere with the course of treatment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of pain ,stiffness, pricking sensation, twitching   0th,7th,14th,28th,42nd day 
 
Secondary Outcome  
Outcome  TimePoints 
To enhance the quality of life by reducing the pain, dependency and improving the functionality   0th,7th,14th,28th,42nd day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   26/12/2024 
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="5"
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   Gridhrasi (Sciatica) is one of the Vatavyadhi caused by aggravated Vatadosha. Included under 80 types of Vataj Nanatmaja Vyadhi. Gridhrasi consist of features like Ruk (continuous pain), Toda (intermittent pricking pain), Stambha (stiffness), Spandana (twitching sensation) over Sphik, Kati, Prishta, Uru, Janu, Jangha extending up to Pada. On the basis of symptoms,Gridhrasi can be clinically correlated with Sciatica.
Sciatica occurs due to spinal nerve irritation and characterized by pain in the distribution of sciatic nerve. The lifetime incidence varying from 13-40% while the annual incidence of an episode of sciatica ranges between 1-5%. Peak incidence occurs in patient in their fourth decade
Sciatica is a condition which incapacitates the patient to perform his daily routine activity due to continuous and stretching type of pain. Conservative management of sciatica încludes administration of NSAIDS, analgesics, muscle relaxant and corticosteroids which gives temporary relief. In some cases, if nerve compression is more, surgical procedure like Laminectomy, discectomy is indicated but this surgical procedure which are quite expensive with their limitations.
Keeping in view about the adverse effects of the modern sciences, there is a need for review our science for an effective, economical, and simple short-term therapy with no side effects and non-recurrence in the management of Sciatica.
In our Ayurvedic Science various modalities of treatment are explained for the management of Gridhrasi are Bheshaj, Snehana, Swedana, Siravyadhana, Agnikarma and Basti. Agni karma chikitsa is even indicated in various painful conditions like joint pain, headache, abdominal cramps/discomfort & few convulsive disorders like epilepsy, schizophrenia & phychosomatic disorders can be treated with this intentional heat burn therapy.
In charkadatta & yogaratnakara we find direct reference of Agnikarma indicated for Gridhrasi. Agnikarma is the most important para surgical procedure. It is said to be better by virtue of its action. It is known to render quick relief. Moreover, Acharya Sushruta appreciates Apunarbhavarva as its prime quality, that means there is no recurrence of diseases treated by agnikarma. Thus it could be a potential area to explore in ayurvedic pain management.
In classics, there are different types of agnikarma have been narrated. Among them Twak dagda & mamsa dagda are of therapeutic significance. The Mamsa dagda can be used for pathologies situated in deeper tissues such as asthi, snayu and sandhi. Based on the targeted area, different materials known as Dalhanopakarana are used to render the heat on effected tissue.For Mamsa dagda, Jambavoshta, loha shalaka, madhu, Sneha, guda and Suchi are advised as choice of material by Vagbhata.
Acharya Vangasena has specified agnikarma with suchi as the treatment modality of Gridhrasi. Compared the classical agnikarma using shalaka, suchi renders deeper penetration and minimal scar. Moreover, its easy availability, inexpensiveness, early heating and better cosmetic outcomes makes it better choice..
To make the method user friendly by avoiding repeated heating, procedure is modified with the support of advanced technology. Viddha karma is one of the eight Shashtra karma mentioned by Acharya Sushruta
Here Suchi in the form of hollow needle will be heated using a cautery machine, which is practiced as Viddhagni. This procedure ensures the heat delivery to the targeted deeper tissue with better cosmetic outcomes. Hence this innovative, improved and user-friendly procedure is adopted for the study.
Hence, the current work is intended to manage Sciatica, a condition which causes significant clinical and public health burdens by exploring effective, safe and cost-effective method of treatment using principles of agnikarma. Also adopting the agnikarma with suchi and modifying it as viddhagni appears to be the best line of intervention in pain management.
Thus, the present study is intended to evaluate the effect of viddhagni karma in subjects fulfilling the criteria of Sciatica vis a vis Gridhrasi.
 
Close