FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056352 [Registered on: 09/08/2023] Trial Registered Prospectively
Last Modified On: 10/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of both classical Panchadhatu Agnikarma and modified Agnikarma in katigraha or Lumbar Spondylosis 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Viddhagnikarma and Agnikarma with Panchadhatu shalaka in Katigraha w.s.r.to Lumbar Spondylosis 
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 NIRMALA BIDARI 
Designation  PG Scholar 
Affiliation  Goverment Ayurvedic Medical College, Bengaluru 
Address  Department of Shalya Tantra Government Ayurvedic Medical College Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  8904132850  
Fax    
Email  nirmalakbidari2014@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srinivas Masalekar 
Designation  Professor and HOD 
Affiliation  Government ayurvedic medical college Bengaluru 
Address  Government Ayurvedic Medical College and hospital Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  9886632966  
Fax    
Email  masalekar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srinivas Masalekar 
Designation  Professor and HOD 
Affiliation  Government ayurvedic medical college Bengaluru 
Address  Government Ayurvedic Medical College and hospital Bengaluru

Bangalore
KARNATAKA
560009
India 
Phone  9886632966  
Fax    
Email  masalekar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic Medical College Bengaluru  
 
Primary Sponsor  
Name  Government Ayurvedic Medical College  
Address  Dhanvantari Road Bengaluru 560009 
Type of Sponsor  Government medical college 
 
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 NIRMALA BIDARI  Shri Jayachamarajendra Government Ayurveda and Unani Hospital Bengaluru  Shalya Tantra opd,Room No 10
Bangalore
KARNATAKA 		 8904132850

nirmalakbidari2014@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, 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:M479||Spondylosis, unspecified. Ayurveda Condition: PRUSHTHA-GRAHAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta samhita, Procedure details: Agnikarma with Panchadhatu Shalaka-patient will be made to lie down in supine position ,most tender points willbe marked by skin marker , and these points will touched by red hot panchadhatu shalaksa , untill samyak dagdha lakshana appers , total 3sittings with 7 days gap will be performed with 30 days followup period))
2Intervention ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Sushruta Samhita, Procedure details: Viddhagnikarma-patient will be made to lie down in supine position ,most tender points willbe marked by skin marker , and these points will be pierced by needle and each needle shaft will be touched by monopolar cautery pin , each needle will be toched for 2to 3 sec like this 3cycles will be done this completes 1sitting , total 3sittings with 7 days gap will be performed with 30 days followup period)
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects with any of following features of Lumbar Spondylosis Low back pain
Stiffness of the back
Tenderness
Pain radiating down the limb up to calf region
Numbness & Paraesthesia over the lateral side of leg or foot
Muscle spasm
Age group between 21 to 60 years

 
 
ExclusionCriteria 
Details  Subjects associated with other systemic disorder like Hyperparathyroidism, Hyper tension, Uncontrolled Diabetes mellitus.
Subjects of spinal diseases like spinal tuberculosis.
Subjects with vertebral fracture and spondylolisthesis, spondylolysis.
Pregnant & Lactating women
Subjects with pace makers
Subjects contra indicated for Agnikarma
Subjects having bleeding disorders, HIV, HBSAG and malignant conditions
Inflammatory conditions like Ankylosing spondylitis
 
 
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 
lower back pain relief  30days 
 
Secondary Outcome  
Outcome  TimePoints 
relief in stiffness, muscle weakness  30days 
 
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 2/ Phase 3 
Date of First Enrollment (India)   15/08/2023 
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="6"
Days="5" 
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  
this study is a randomized comparative clinical study to evaluate the efficacy of agnikarma in pain management and stiffness relief in case of katigraha wsr to lumbar spondylosis .group a containing 20 subjects is subjected to viddhagnikarma for 3sitting followup done for further 30days ,
   in the same way group b consisting of 20 subjects will be subjected to agnikarma with panchadhatu shalaka ,and followup done for further 30 days .in opd and ipd of shri jayachamarajendra ayurveda and unani hospital ,dhanvantari road bengaluru.
   primary outcome will be relief in lower back pain and secondary outcome will be relief in stiffness in lumbar region , and muscle weakness
 
Close