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CTRI Number  CTRI/2025/07/090753 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to know the effect of agnikarma over the little toe with tamra shalaka in the management of gridrasi (sciatica) 
Scientific Title of Study   A Clinical study to evaluate the effect of agnikarma over the padakanishtika anguli (little toe) with tamra shalaka in the management of gridhrasi With special reference to 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 Aditya Rv 
Designation  post graduation scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara college of ayurveda 
Address  Department of pg studies in Shalya Tantra, Sri Dharmasthala Manjunatheshwara college of ayurveda, kuthpady, udupi
Sri Dharmasthala Manjunatheshwara college of ayurveda, kuthpady, udupi
Udupi
KARNATAKA
57411
India 
Phone  9480134269  
Fax    
Email  adityavr717@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Rn 
Designation  Associate professor  
Affiliation  Sri Dharmasthala Manjunatheshwara college of ayurveda 
Address  Department of pg studies in Shalya Tantra, Sri Dharmasthala Manjunatheshwara college of ayurveda, kuthpady, udupi
Sri Dharmasthala Manjunatheshwara college of ayurveda, kuthpady, udupi
Udupi
KARNATAKA
57411
India 
Phone  9449753320  
Fax    
Email  rakesharyan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditya Rv 
Designation  post graduation scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara college of ayurveda 
Address  Department of pg studies in Shalya Tantra, Sri Dharmasthala Manjunatheshwara college of ayurveda, kuthpady, udupi
Sri Dharmasthala Manjunatheshwara college of ayurveda, kuthpady, udupi
Udupi
KARNATAKA
57411
India 
Phone  9480134269  
Fax    
Email  adityavr717@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Aditya rv  
Address  Sri Dharmasthala Manjunatheshwara college of ayurveda, kuthpady, udupi 574118 
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 Aditya rv  Sri Dharmasthala Manjunatheshwara College of Ayurveda  Department of Shalya Tantra
Udupi
KARNATAKA 		 9480134269

adityavr717@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Ayurveda Institutional ethical clearance committee Human   No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Chakradatta Chikitsa Sangarahana, Treatment of Vata Vyadi; Chapter 22, verse 56, Procedure details: Agnikarma will be performed on day one over the little toe by using Agnitaptha Tamra shalaka)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with the symptoms of Gridhrasi that is pain over the Sphik (gluteal region) Kati Prishta (back), Uru (thigh), Janu (knee), Jangha (calf region) extending up to Pada (foot); Stambha (stiffness), Toda (pricking pain), numbness of limbs, tingling sensation and Paraesthesia of legs and the age group of 18-60 years included.
1.Patients with positive SLR test (straight leg test).
2.Patients with prior written consent.

 
 
ExclusionCriteria 
Details  1.Patients contraindicated for Agnikarma as per texts.
2.Patients who have skeletal abnormalities those are congenital.
3.Patients with tumors (Benign and carcinogenic) and Tuberculosis in the spine.
4.Any cyst which compresses the nerve root.
5.Patients with traumatic spine fractures.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in Ruja  One hour 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in supti, stamba  one day after Agnikarma  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   25/07/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [adityavr717@gmail.com].

  6. For how long will this data be available start date provided 05-07-2025 and end date provided 05-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The word ‘Gridhrasi itself suggests the gait of the patient which is similar to Gridhra (vulture) due to extreme pain in low back region, radiating towards Pada, where the Dusta Vayu affects the Kandara (nerves) which lies between Prashni (heel) and Anguli (Fingers). The symptoms of Gridhrasi resembles with symptoms of Sciatica. Sciatica is defined as a radiating pain along the course of the sciatic nerve due to the compression or irritation of nerve roots of L4 - S3 and is felt in the low back, buttocks, posterior of the thigh, legs and foot.  Worldwide lifetime incidence reported between 10-40 percentage with an annual report of 1–5 percentage Occupational predisposition shown in machine operators, truck drivers, Sciatica cases reported most commonly in the age group of 25- 45 years. In modern medicine treatment like NSAID’S, Steroid which provides short-term relief and surgical intervention with varying results. The recurrence rate is about 72-90 percentage. Agnikarma has the capability to cure chronic diseases which cannot be cured by Bheshaja, Shastra and Kshara Karma. Hence Agnikarma is done in Padakinsthakam which will be effective in Gridharsi. Tamra Shalaka is more effective than Louha and Panchadhatu Shalaka due to its better effect in controlling symptoms like Toda, Stambha of Gridhrasi. Tamra Dhathu has a property of absorbing heat in short duration and holding it for long duration. Hence there is an emerging need to search for an more effective, safer and cost-effective option for the same.

 
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