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CTRI Number  CTRI/2025/09/094400 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Kubja Prasarini Taila nasya in Cervical Spondylosis 
Scientific Title of Study   Clinical Evaluation of Kubja Prasarini Taila Nasya in 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  Meenakshi Arya 
Designation  PG Scholar 
Affiliation  Uttarakhand Ayurved University Gurukul Campus, Haridwar 
Address  Department of Panchakarma Gurukul Campus Uttarakhand Ayurved University Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9027399536  
Fax    
Email  meenakshi.arya131998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shikha Pandey 
Designation  Assistant Professor 
Affiliation  Uttarakhand Ayurved University, Gurukul Campus, Haridwar 
Address  Department of Panchakarma Gurukul Campus Uttarakhand Ayurved University Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  8267837981  
Fax    
Email  shikha89.pandey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meenakshi Arya 
Designation  PG scholar 
Affiliation  Uttarakhand Ayurved University Gurukul Campus, Haridwar 
Address  Department of Panchakarma Gurukul Campus Uttarakhand Ayurved University Haridwar

Hardwar
UTTARANCHAL
249404
India 
Phone  9027399536  
Fax    
Email  meenakshi.arya131998@gmail.com  
 
Source of Monetary or Material Support  
Gurukul Campus, Uttarakhand Ayurved University Haridwar, 249404 
 
Primary Sponsor  
Name  Gurukul Campus Uttarakhand Ayurved University Haridwar  
Address  Gurukul Campus, Uttarakhand Ayurved University Haridwar,249404 
Type of Sponsor  Government medical college 
 
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 
DrMeenakshi Arya  Uttarakhand Ayurved University Gurukul Campus, Haridwar  OPD no 24 department of panchakarma,Gurukul Campus, Uttarakhand Ayurveda University,Haridwar,249404
Hardwar
UTTARANCHAL 		 9027399536

meenakshi.arya131998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Uttarakhand ayurved university Gurukul Campus, Hardwar.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charak Samhita, Procedure details: Sthanik abhyang swedan done followed by nasya karma)
(1) Medicine Name: Kubja Prasarini Taila, Reference: Chakradutta, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with classical sign and symptoms of cervical spondylosis
2. Patients fit for Nasya Karma 
 
ExclusionCriteria 
Details  1. Patients of pregnancy and lactating mother
2. Patients with other systemic disorders that interfere in the line of treatment.
3. Patients with congenital deformity, Traumatic injuries, ankylosing spondylitis, Rheumatoid arthritis, hyperuricemia.
4. patients having serious illness like uncontrolled Hypertension, Diabetes, Asthma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement will be assessed on the basis of subjective and objective parameters - by grading scale adopted for this study.
1. Neck Disability Index (NDI)
2. Visual Analogue Scale (VAS)
3. Range of movement
4. Muscle power
5. Reflexes 		 Assessment will be done at baseline and after 3 weeks of completion of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
X-ray
Vertigo 		 At baseline & after 3 weeks of completion of treatment. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   27/09/2025 
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="6"
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   Spondylosis is a specific kind of arthritis which involves Vertebrae, inter- vertebral discs & ligament, characterized by pain, stiffness of neck, occipital headache, giddiness and is very much resembles to Manyastambh. In Chakradutt, Acharya Chakrapani has indicated Kubja Prasarini Taila in Manyastambh.This study is single arm open label trial for efficacy of Kubja Prasarini Taila Nasya in Cervical Spondylosis. This study will be conducted at UAU, Gurukul Campus Haridwar in 30 patients. The assesment will be done on the basis of subjective and objective parameters. The study will be conducted at OPD and IPD level of PG department of Panchakarma. 
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