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CTRI Number  CTRI/2018/10/015990 [Registered on: 10/10/2018] Trial Registered Prospectively
Last Modified On: 09/10/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of Prasrini taila administration through nasal and through anus in treatment of Cervical spondylosis. 
Scientific Title of Study   An Open Randomised Clinical Study to Evaluate the Comparative Efficacy of Nasya and Matra Basti with Prasarini Taila in the Management of Greevastambh w.s.r. to Cervical Spondylosis 
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,Department of Panchakarma, National Institute of Ayurveda Jaipur Jaipur RAJASTHAN 302002 India
302002 India 
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,Department of Panchakarma, National Institute of Ayurveda Jaipur Jaipur RAJASTHAN 302002 India
302002 India 
Jaipur
RAJASTHAN
302002
India 
Phone  8739860237  
Fax    
Email  sarveshksingh21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saroj Kumari 
Designation  M. D. Scholar 
Affiliation  National Institute of Ayurveda Jaipur  
Address  Room no.2,Department of Panchakarma, National Institute of Ayurveda Jaipur Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9468908043  
Fax    
Email  drsarojkumari99@gmail.com  
 
Source of Monetary or Material Support  
National institute of Ayurveda Jorawar singh gate Jaipur, Rajasthan,India  
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
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.
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: M478||Other spondylosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Anal administration of Matra Basti in the dose of 75 ml once a day with Prasarni Taila for 14 days.    Matra Basti(anal administration of oil) will be done after local massage and fomentation of lower abdomen with Prasarani Taila in the dose of 75 ml once a day for 14 days.   
Intervention  Nasal administration of Parsarini Taila in the dose of 8 drops (6ml)in each nostril once a day for 14 days.  Nasal administration of Parsarini Taila in the dose of 8 drops (6ml)in each nostril once a day 14 days after proper swedana (sudation) of head,face and neck region.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  (1)Patients with features of Greevastambh (Cervical spondylosis)
(2)Patients fit for Nasya and Matra Basti.
(3)Patients having sign and symptoms supported by X-ray findings as per Visual Analog Scale, Modified Japanese Orthopedic Score) 
 
ExclusionCriteria 
Details  (1)Patients suffering from rheumatoid arthritis, gout, ankylosing spondylitis.
(2)Patients with major systemic disorders.
(3)Patients with stenosis of spinal canal, myelopathy.
(4)Pregnant women and lactating mother.
(5)Patients with any surgical history at cervical region.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in modified Japanes orthopaedic association score (mJOA score) and range of movement  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
changes in VAS score and global assessement of disease activity.  45 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   01/01/2019 
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="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   yet not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The trial is an open label randomized clinical trial. The primary aim of the trial is to compare the efficacy of Nasya Karma(nasal administration) with Prasarini Taila(oil) and efficacy of Matra Basti (anal administration)of Prasarini Taila ( oil) in the management of  Greevastambh  w.s.r. to Cervical Spondylosis. Total 60 patient will be taken for trial. The patient will be randomly divided into two groups of 30 patients each. In group A Nasya Karma with Prasarini  taila in the dose of 8 drops (6ml) in each nostril will be done for 14 days .In group B  Matra Basti( anal administration ) of Prasarini  taila in the dose of 75ml  once a day for 14 days . The primary outcome will be the improvement in  total score of mJOA and range of motion.The patient will be  finally assessed after 45 days  of treatment.  
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