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CTRI Number  CTRI/2017/03/008161 [Registered on: 21/03/2017] Trial Registered Retrospectively
Last Modified On: 15/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   treatment of sciatica with agnikarma and siravedhan. 
Scientific Title of Study   A comparative study on the efficacy of agnikarma and siravyadha in the management of Gridhrasi(Sciatica). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rachna Kanzaria 
Designation  M.S.(ayu) 2nd year scholar 
Affiliation  Govt.Akhandanand Ayurved Mahavidyalaya, GAU 
Address  Department of Shalyatantra, Govt. Akhandanand Ayurved college-hospital, Bhadra, Ahmedabad.
C/O, Payal Novelty, Satwara Vad, street no.-5, Jamkhambhaliya. Dist.- devbhumi dwarka
Ahmadabad
GUJARAT
380001
India 
Phone  9824779502  
Fax    
Email  rachna_kanzaria@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa MP 
Designation  HOD of shalyatantra department 
Affiliation  Govt. Akhandanand Ayurved Mahavidyalaya 
Address  Department of Shalyatantra, Govt. Akhandanand Ayurved College- Hospital, Bhadra, Ahmedabad.

Ahmadabad
GUJARAT
380001
India 
Phone  08511082205  
Fax    
Email  drshilpavinay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pragnesh Patel 
Designation  Assistant professor 
Affiliation  Govt.Akhandanand Ayurved Mahavidyalaya, GAU 
Address  Department of Shalyatantra, Govt. Akhandanand Ayurved College- Hospital, Bhadra, Ahmedabad.

Ahmadabad
GUJARAT
380001
India 
Phone  8140640999  
Fax    
Email  prayuin@gmail.com  
 
Source of Monetary or Material Support  
Govt. Akhandanand Ayurved College and Hospital,Smt.Maniben Ayurved Hospital, Ahmedabad 
 
Primary Sponsor  
Name  Govt Akhandanand Ayurved College and Hospital and Maniben Ayurved Hospital 
Address  Govt. Akhandanand Ayurved College, Bhadra, Ahmedabad. Smt. Maniben Ayurved Hospital, Asarva, Ahmedabad. 
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 Rachna Kanzaria  Government. Akhandanand Ayurved hospital and Smt. Maniben Ayurved Hospital  room no. 24, OPD of Dept. of Shalyatantra, Govt. Akhandanand ayurved hospital, bhadra, ahmedabad. Smt. maniben ayurved hospital, Asarva, Ahmedabad
Ahmadabad
GUJARAT 		 9824779502

rachna_kanzaria@yahoo.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  Gridhrasi (Sciatica),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Agnikarma  Accupuncture needle to be inserted at antara-kandara-gulpha pradesh(around ankle joint) and heat to be given from outside with lighter till patient feels burning pain. 
Comparator Agent  siravyadha  Superficial vein below knee joint to be punctured with scalpvein needle. wait till the blood stops itself. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) The patients suffering from salient features of Gridhrasi (ruk, toda, stambha, spandananubhuti & positive SLR test).
2) Patients of any religion, caste, occupation will be included.
 
 
ExclusionCriteria 
Details  patients suffering from-
1) Diabetes mellitus
2) Cancer of lumbosacral plexus
3) Cancer of Cauda equina
4) Pregnancy
5) HIV positive
5 )HBsAg positive
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduced pain and improvement in walking.  from just after the procedure to period of 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
safety from other complication.  just after the procedure to seven days after the procedure. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   13/07/2016 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is an open uncntrolled randomised clinical comparative study of the two treatments described in ayurveda literature for  patients having sciatica. 
Till now only Tvakdagdha Agnikarma has been done which has been approved effective. Acharya Sushruta has described Mansagata Agnikarma too. so here trying to find the efficacy of Mansagata Agnikarma Procedure.
An accupuncture needle is to be inserted at antara-kandara-gulfpradesha and heat is to be given with lighter from the end outside till the samyak mamsadagdha laxana appears.
Same way, Siravyadha procedure is also described in samhita. siravedhan is to be done at superficial protruded vein from the poplitial fossa with scalpvein needle no.20.
25 patients in each group will be treated with these two different procedures named as Agnikarma and Siravyadha. 

 
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