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CTRI Number  CTRI/2018/10/016140 [Registered on: 24/10/2018] Trial Registered Prospectively
Last Modified On: 28/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of nasal therapy with Vrihatjivakadya Tail in the management of migraine. 
Scientific Title of Study   To evaluate the comparative efficacy of Nasya by Vrihatjivakadya Taila prepared from Mridu Snehapaka and Madhyama Snehapaka in the management of Ardhavbhedaka w.s.r.migraine.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarvesh Kumar Singh 
Designation  Assistant Professor  
Affiliation  National Institute of Ayurveda Jaipur  
Address  Room No 2 PG Department of Panchakarma,National institute of Ayurveda,Madhav Vilas Jaipur,Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8739860237  
Fax    
Email  sarveshksingh21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarvesh Kumar Singh 
Designation  Assistant Professor  
Affiliation  National Institute of Ayurveda Jaipur  
Address  Room No 2 PG Department of Panchakarma,National institute of Ayurveda,Madhav Vilas Jaipur,Rajasthan 302002
Room No 2 PG Department of Panchakarma,National institute of Ayurveda,Madhav Vilas Jaipur,Rajasthan 302002

RAJASTHAN
302002
India 
Phone  8739860237  
Fax    
Email  sarveshksingh21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Avadhesh kumar 
Designation  M. D. Scholar 
Affiliation  National Institute of Ayurveda Jaipur  
Address  Room No 2 PG Department of Panchakarma,National institute of Ayurveda,Madhav Vilas Jaipur,Rajasthan 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8573909559  
Fax    
Email  dr.avadheshgautam@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Madhav Vilas hospital,Jorawar Singh Gate Jaipur. 
 
Primary Sponsor  
Name  National institute of Ayurveda Jorawar singh gate Jaipur RajasthanIndia  
Address  Madhav Vilas Hospital,Jorawar Singh Gate,Jaipur,Rajasthan,India    
Type of Sponsor  Research institution and hospital 
 
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 Sarvesh Kumar Singh  National Institute of Ayurveda, Jaipur   Room no.2,Department of Panchakarma, Madhav Vilas,Joravar Singh Gate National Institute of Ayurveda Jaipur Jaipur RAJASTHAN 302002 India Jaipur Jaipur RAJASTHAN 
Jaipur
RAJASTHAN 		 8739860237

sarveshksingh21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commitee, National Institute of Ayurveda Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G431||Migraine with aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nasal administration of Brihatjivakadya Taila (lower viscosity) in the dose of 6 drops (4.5 ml)in each nostril once a day for 14 days.   Nasal administration of Vrihatjivakadya Taila (lower viscosity)in the dose of 6 drops (4.5ml)in each nostril once a day 14 days after proper swedana (sudation) of head,face and neck region.  
Intervention  Nasal administration of Vrihatjivakadya Taila(medium viscosity) in the dose of 6 drops (4.5ml)in each nostril once a day for 14 days.   Nasal administration of Vrihatjivakadya Taila (medium viscosity) in the dose of 6 drops (4.5ml)in each nostril once a day 14 days after proper swedana (sudation) of head,face and neck region.  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  (1)Patients with clinical signs and symptoms of Ardhavbhedaka.
(2)Patients fit for Nasya Karma.
 
 
ExclusionCriteria 
Details  (1)Patients with severe systemic disorders.
(2)Patients of sinusitis, hemiplegic migraine, basilar migraine, retinal migraine and status migranosus.
(3)Patients with headache due to any organic lesion and chronic systemic disease.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in MIDAS(Migraine Disability assessment Score)  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in symptoms of Ardhavbhedaka.  45 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "89"
Final Enrollment numbers achieved (India)="89" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/01/2019 
Date of Study Completion (India) 18/04/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 The trial is a double blinded randomized clinical trial. The primary aim of the trial is to compare the efficacy of Nasya Karma(nasal administration) with Vrihatjivakadya Taila(oil) of Mridu Snehapaka( lower viscosity) and efficacy of Nasya karma (nasal administration) of Vrihatjivakadya Taila ( oil) with  Madhyama Snehapaka (medium viscosity)   in the management of  Ardhavbhedaka w.s.r. Migraine. Total 100 patients were taken for trial. The patients were randomly divided into two groups of 50 patients each. In group A Nasya Karma with Vrihatjivakadya  taila  of Mridu Snehapaka in the dose of 6 drops (4.5ml) in each nostril was done for 14 days .In group B  Vrihatjivakadya Taila of Madhyama snehapaka in the dose of 6 drops (4.5 ml) in each nostril was done for 14 days . The primary outcome was the improvement in  MIDAS score.The patients were  finally assessed after 45 days  of treatment.   
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