FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/02/023182 [Registered on: 07/02/2020] Trial Registered Prospectively
Last Modified On: 31/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of two oil nasya, Prabhanjanavimaradana Taila and Tila taila in patients with cervical spondylosis  
Scientific Title of Study   “Double-blind comparative clinical study on Prabhanjanavimardana Taila and Tila taila Nasya in Vishwachi” 
Trial Acronym  PAT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lifam Roshanara 
Designation  M.D Scholar 
Affiliation  ALVA’S AYURVEDA MEDICAL COLLEGE AND HOSPITAL 
Address  DEPARTMENT OF PG STUDIES IN PANCHAKARMA ALVA’S AYURVEDA MEDICAL COLLEGE AND HOSPITAL MOODBIDIRI DK DISTRICT
MOODBIDIRI D.K DISTRICT KARNATAKA-574227
Dakshina Kannada
KARNATAKA
574227
India 
Phone  8151835408  
Fax    
Email  lifamr2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Vikram Kumar 
Designation  Associate professor 
Affiliation  ALVA’S AYURVEDA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of P.G. studies in panchakarma, Alva’s Ayurveda Medical College and Hospital, Moodbidiri, D.K District, Karnataka-574227.

Dakshina Kannada
KARNATAKA
574227.
India 
Phone  9483141326  
Fax    
Email  vikramkumar83@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Llifam Roshanara 
Designation  M.D Scolar 
Affiliation  ALVA’S AYURVEDA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of P.G. studies in Panchakarma, Alva’s Ayurveda Medical College and Hospital, Moodbidiri, D.K District, Karnataka-574227.

Dakshina Kannada
KARNATAKA
574227.
India 
Phone  8151835408  
Fax    
Email  lifamr2@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical college and hospital,Vidyagiri, Moodbidri,D.k District, Karnataka-574227 
 
Primary Sponsor  
Name  Yakoob Ahmed Salam 
Address  Al-FAthah ahmed manzil Annebadi Gurupura Post Manglore D K Karnataka 574145  
Type of Sponsor  Other [Father] 
 
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 lifam roshanara  Alva’s Ayurveda Medical College and Hospital  Panchakarma theatre Department of Panchakarma room number 201 second floor,Vidyagiri , Moodbidri, D.K District, Karnataka-574227.
Dakshina Kannada
KARNATAKA 		 8151835408

lifamr2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Clinical Ethical Committee Alvas Ayurveda Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Moorchita Tila Taila  Each patient will be subjected to Moorchita Tila Taila Nasya 4ml in each nostril once a day for 7 days. 
Intervention  Prabhanjanvimardana Taila  Each patient will be subjected to Prabhanjanavimardana Taila Nasya 4ml in each nostril once a day for 7 days 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with symptoms of Vishwachi between age group 30 - 70 years of either sex.
Patients who are fit for Nasya Karma.
 
 
ExclusionCriteria 
Details  Patients with the history of recent trauma, congenital anomalies of cervical spine.
Patients contra-indicated for Nasya karma. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Neck pain
Neck stiffness
Tingling sensation
Neck disability index17
Tenderness on neck and upper limb
Range of movement
 		 2 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/02/2020 
Date of Study Completion (India) 01/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is randomised ,double blind,parallel group,single centre trial comparing efficacy of Prabhanjanavimardana Taila and Tila Taila Nasya  daily for 7 days in 40 patient with Vishwachi that will be conducted in Alva’s Ayurveda Medical college Vidyagiri Moodbidri Dakshina kannada India.Primary out come measure will be relief from Neck pain,neck stiffness,tingling sensation,neck tenderness,range of movement,neck disability index in 2 month.
 
Close