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
|
|
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
|
|
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. |