FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066344 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect of Siravedha and Conductive Agnikarma with suvarna shalaka in two group of 20 patients of Gridhrasi w.s.r. to Sciatica 
Scientific Title of Study   A comparative clinical study to evaluate the effectiveness of Siravedha and conductive Agnikarma with suvarna shalaka in the management of Gridhrasi w.s.r. 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 Abhiranjan 
Designation  MD(Ay.) Scholar (Dept. of Panchkarma) 
Affiliation  Government Ayurvedic College and Hospital 
Address  Dept. of Panchkarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan

Patna
BIHAR
800003
India 
Phone  9958141342  
Fax    
Email  abhiranjankumar85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhilesh Prasad Singh 
Designation  HOD & Asso. Prof. Dept of Panchkarma 
Affiliation  Government Ayurvedic College and Hospital 
Address  Dept. of Panchkarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan

Patna
BIHAR
800003
India 
Phone  8002680973  
Fax    
Email  drapsinghpatna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Prasad Singh 
Designation  HOD & Asso. Prof. Dept of Panchkarma 
Affiliation  Government Ayurvedic College and Hospital 
Address  Dept. of Panchkarma, Govt. Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan

Patna
BIHAR
800003
India 
Phone  8002680973  
Fax    
Email  drapsinghpatna@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan, Patna, Bihar- 800003 
 
Primary Sponsor  
Name  Dr. Abhiranjan 
Address  Dept. of Panchkarma, Government Ayurvedic College and Hospital, Near Buddha Murti, Kadamkuan, Patna, Bihar- 800003 
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 Abhiranjan  Government Ayurvedic Medical College and Hospital   OPD No. 11, Panchkarma Department, Near Buddha Murti Kadamkuan
Patna
BIHAR 		 9958141342

abhiranjankumar85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC)  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-sirAvedhaH, सिरावेधः (Procedure Reference: Charak Samhita Chikitsasthana 28/101, Procedure details: Using 20 gauge scalp vein set blood letting will be done from prominent vein around ankle region post local snehana and swedana, total 4 sittings, 1 sitting per week)
2Comparator ArmProcedure-agnikarma, अग्निकर्म (Procedure Reference: Charak Samhita Chikitsasthana 28/101, Procedure details: Conductive Agnikarma will be done with Suvarna Shalaka at nerve roots region of Sciatica nerve, total 4 sittings, 1 sitting per week)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The presence of Ruka, Toda, Stambha and spandana in the sphik, kati, uru, janu, jangha and pada.
Tenderness along the Sciatic nerve.
SLR test positive as an objective measure of diagnosis and assessment. 
 
ExclusionCriteria 
Details  Contraindicated for Siravedha and Conductive Agnikarma.
Known cases of other major illness like DM, TB, AIDS and Malignancy.
Pregnancy.
Anaemic Hb. less than 10 mg/dl
Age below 20 years and above 70 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Relief in sign and symptoms of Gridhrasi i.e. Ruka
( Pain )

, Stambha
(Stiffness)
, Toda
( Pricking
sensation), Aruchi
( Anorexia ), Tandra (lethargy), Gaurav (heaviness).
2. Relief in low back pain symptoms like pulling pain, stiffness, pricking sensation. 		 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. changes in X-ray LS Spine  60 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 
Date of First Enrollment (India)   06/05/2024 
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="0"
Months="8"
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

  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 [abhiranjankumar85@gmail.com].

  6. For how long will this data be available start date provided 03-03-2025 and end date provided 04-03-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized, open, parallel group, interventional prospective trial comparing the effectiveness of Siravedha and conductive Agnikarma with Suvarna Shalaka in the management of Grudhrasi w.s.r. to sciatica, that will be conducted in Government Ayurvedic Medical College and Hospital at Patna, Bihar in the Department of Panchkarma. In each group of 20 patients, Siravedha from promient vein around Ankle region will be done weekly once and total 4 sittings will be done and and in the another group Conductive Agnikarma with Suvarna Shalaka will be done at nerve roots of sciatica nerve and total 4 sittings will be done, weekly once. Post intervention follow-up will be done every 15 days for total duration of study i.e. of 60 days. 
Close