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CTRI Number  CTRI/2025/04/085480 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 23/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   THE EFFECT OF NASYA KARMA AND MATRA BASTI WITH KSHEERABALA TAILA IN GREEVASTAMBHA W.S.R. TO CERVICAL SPONDYLOSIS 
Scientific Title of Study   RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF NASYA KARMA AND MATRA BASTI WITH KSHEERABALA TAILA IN THE MANAGEMENT OF GREEVASTAMBHA W.S.R. TO CERVICAL SPONDYLOSIS 
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 Ghanshyam Beniwal 
Designation  Pg scholar 
Affiliation  MMMGAC Udaipur Rajasthan 
Address  Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Udaipur RAJASTHAN 313001 India
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Udaipur RAJASTHAN 313001 India
Udaipur
RAJASTHAN
313001
India 
Phone  07976104054  
Fax    
Email  beniwalghanshyam04@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajeev Kumar Pandey 
Designation  Associate Professor 
Affiliation  Madan Mohan Malviya Goverment Ayurved collage udaipur Rajasthan 
Address  Associate Professor PG Department of Panchakarma Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Udaipur RAJASTHAN 313001 India
Associate Professor PG Department of Panchakarma Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Udaipur RAJASTHAN 313001 India
Udaipur
RAJASTHAN
313001
India 
Phone  07976104054  
Fax    
Email  rajeevpanchakarma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajeev Kumar Pandey 
Designation  Associate Professor 
Affiliation  Madan Mohan Malviya Goverment Ayurved collage udaipur Rajasthan 
Address  Associate Professor PG Department of PanchakarmaAssociate Professor PG Department of Panchakarma Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Udaipur RAJASTHAN 313001 India
Associate Professor PG Department of Panchakarma Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Udaipur RAJASTHAN 313001 India
Udaipur
RAJASTHAN
313001
India 
Phone  07976104054  
Fax    
Email  rajeevpanchakarma@gmail.com  
 
Source of Monetary or Material Support  
MMMGAC 
 
Primary Sponsor  
Name  MMMGAC 
Address  MMMGAC RADAJI CIRCLE UDAIPUR 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
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 
Ghanshyam Beniwal  Mohan Malviya Government Ayurved College Udaipur Rajasthan Udaipur RAJASTHAN   OPD 1,2,3,4,GOVERMENT AYURVEDA RESEARCH CENTER MMMGAC UDAIPUR
Udaipur
RAJASTHAN 
07976104054

beniwalghanshyam04@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC MADAN MOHAN MALVIYA AYURVEDA COLLEGE UDAIPUR  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 
Intervention  Ksheerabala Taila  Ksheerabala Taila Matra Basti for 14 consecutive days 
Comparator Agent  Ksheerabala Taila  Ksheerabala Taila Nasya Karma for 14 Consecutives Days 
 
Inclusion Criteria  
Age From  16.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  (1)Patients suffering from classical signs and symptoms of Greevastambha w.s.r. to cervical spondylosis.

(2)Patient willing and able to participate in the study for 14 days and follow up period of 30 days.

(3)Neurological deficits consistent with cervical spine pathology. 
 
ExclusionCriteria 
Details  (1)Patients suffering from any acute diseases, infectious diseases, metabolic diseases, chronic diseases (like rheumatoid Arthritis, Uncontrolled DM, Gout, TB, SLE, Ankylosing spondylitis etc.).

(2)Patient contraindicated for Nasya Karma.
(3)Acute trauma to the cervical spine.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reducation in pain in cervical spondylosis patients  Follow up on 30th and 45th day of enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
Reducation in Stiffness in cervical spondylosis Patients  Follow up on 30th and 45th day of enrollment 
 
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 2/ Phase 3 
Date of First Enrollment (India)   04/05/2025 
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="0"
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 - NO
Brief Summary  

Cervical Spondylosis is a degenerative condition and modern modalities have no sustained remedy to stop degeneration. In this period of modernization and fast life, people undergo improper sitting posture for long time in offices, continuous work in one posture and over exertion, load bearing movements during travelling and sports stress etc. which increases the incidence of this disease.

Cervical spondylosis is common degenerative condition of cervical spine in the general population with incidence rate of 83 per 100,000 populations and prevalence of 3.3 cases per 1000 people and occurs mostly in fourth and fifth decades of life5. Cervical Spondylosis commonly occurred below 30 years of age.

 
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