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CTRI Number  CTRI/2024/06/069268 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Study of Ksheerbala Tail Nasya and Ashwagandha Tail Nasya in the management of cervical spondylosis 
Scientific Title of Study   An Open Labelled Randomised Controlled Clinical Study to evaluate the efficacy of Ksheerbala Tail Nasya and Ashwagandha Tail Nasya in the management of 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 Surbhi 
Designation  M D Panchkarma Scholar  
Affiliation  Institute for Ayurved Studies and Research 
Address  Room No 69 First Floor Department of Panchkarma Institute for Ayurved Studies & Research Shri krishna Ayush University Umri Road Sector 08 Kurukshetra Haryana India 136118

Kurukshetra
HARYANA
136118
India 
Phone  7988705175  
Fax    
Email  surbhibudhiraja123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Ashish Mehta  
Designation  Professor 
Affiliation  Institute for Ayurved Studies and Research 
Address  Room No 67 First Floor Department of Panchkarma Institute for Ayurved Studies & Research Shri krishna Ayush University Umri Road Sector 08 Kurukshetra Haryana India 136118

Kurukshetra
HARYANA
136118
India 
Phone  8950375285  
Fax    
Email  drashishhmehta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surbhi  
Designation  M D Panchkarma Scholar 
Affiliation  Institute for Ayurved Studies and Research 
Address  Room No 69 First Floor Department of Panchkarma Institute for Ayurved Studies & Research Shri krishna Ayush University Umri Road Sector 08 Kurukshetra Haryana India 136118

Kurukshetra
HARYANA
136118
India 
Phone  7988705175  
Fax    
Email  surbhibudhiraja123@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies & Research Shri Krishna Ayush University Umri Road Sector 08 Kurukshetra Haryana India 136118 
 
Primary Sponsor  
Name  Institute for Ayurved Studies & Research 
Address  Institute for Ayurved Studies & Research Shri Krishna Ayush University Umri Road Sector 08 Kurukshetra Haryana India 136118 
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 
Dr Surbhi  Institute for Ayurved Studies and Research  Room No 69 First Floor Department of Panchkarma
Kurukshetra
HARYANA 		 7988705175

surbhibudhiraja123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central ethics committee on human research of ICMR, New Delhi  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: ASTHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushruta Samhita Chikitsa Sthan 40, Procedure details: After massaging, oil is instilled in each nostril. Spit the oil that comes in mouth. After that medicated smoking & gargling is done. This will take about 25 minutes. 7 sittings will be done in between 7 to 21 days.)
(1) Medicine Name: Ksheerbala oil, Reference: Sahastra Yogam, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 08(ml), Frequency: od, Duration: 07 Days
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Sushruta Samhita Chikitsa Sthan 40, Procedure details: After massaging, oil is instilled in each nostril. Spit the oil that comes in mouth. After that medicated smoking & gargling is done. This will take about 25 minutes. 7 sittings will be done in between 7 to 21 days.)
(1) Medicine Name: Ashwagandha oil, Reference: Chakradatta Vata Vyadhi 22, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 08(ml), Frequency: od, Duration: 07 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Patients willing to sign the consent form.
2 Patients aged between 25 and 55 yrs of either sex.
3 Patients having signs and symptoms of cervical spondylosis exceeding not more than 3 years with or without radiological changes.
4 Patients fit for Nasya Karma.
 
 
ExclusionCriteria 
Details  1 Patients having age below 25 and above 55 yrs of either sex.
2 Patients with chronicity of more than 3 years.
3 Patients unfit for Nasya karma.
4 Patients not willing for the Nasya karma.
5 Patients diagnosed with Myelopathy or stenosis of Spinal Canal, and other related conditions like Ankylosing spondylitis.
6 Patient diagnosed with Tuberculosis of spine, spinal tumors, Vascular lesions, Neoplasms, history of trauma, fractures and surgical history.
7 Patients having any other systemic disorders like cardiac disease, renal diseases and hypertension or endocrinal disorders.
8 Pregnant or lactating mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in scoring pattern of subjective parameters of Cervical Spondylosis like Pain, Stiffness, Tenderness, Headache, Vertigo, Tingling sensation and Sensory loss.
Reduction in scoring pattern of objective parameters of Cervical Spondylosis like ROM of neck flexion, extension, lateral rotation, lateral flexion, Reflexes, Muscle power strength.
 		 On 1st, 8th, 15th day of treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
To relief the pain and discomfort of patients suffering from Cervical Spondylosis  On 1st, 8th, 15th day of treatment 
 
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/ Phase 4 
Date of First Enrollment (India)   03/07/2024 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [surbhibudhiraja123@gmail.com].

  6. For how long will this data be available start date provided 31-07-2024 and end date provided 30-07-2034?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Cervical pain is experienced by all most all individuals in their life span and disturbs the routine. Cervical spondylosis is due to a degeneration at the level of Cervical spine or an inflammatory reaction in association with an early degenerative change at that level. In Ayurvedic context, sign and symptoms of Cervical spondylosis is best correlates with asthi-majjagat vata. As Cervical spondylosis is one of the conditions occurring at manya pradesh, hence it is urdhwajatrugata vikara so nasya is the choice of treatment. As it is a degenerative disorder so brhimhana, vatashamaka and dhatuposhak ausdhi will be admisinistered. As bala and ashwagandha possess madhur, snigdha and dhatuposhak properties the efficacy of ksheerbala tail nasya in Cervical spondylosis is proved in previous research work. No work is done yet on ashwagandha tail nasya in Cervical spondylosis so this comparative study is selected for research. 

Aim: To evaluate the efficacy of ashwagandha tail nasya in management of Cervical spondylosis.

Objective: To evaluate efficacy of ashwagandha tail nasya in comparison with ksheerbala tail nasya in management of Cervical spondylosis. 

Methodology: Total 60 patients of Cervical spondylosis will be selected randomly and divided in to 2 groups i.e. Group A (ksheerbala tail nasya) and group B (ashwagandha tail nasya). Nasya will be given for 7 sittings between 7-21 days in dose of 8 bindu in each nostril. And observation will be done on basis of before and after subjective and objective parameters.

 
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