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CTRI Number  CTRI/2022/04/041727 [Registered on: 07/04/2022] Trial Registered Prospectively
Last Modified On: 05/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Difference between Dashamooladi yamaka sneha and shuddhabala taila nasya in treatment of Cervical Radiculopathy 
Scientific Title of Study   Comparative Evaluation of Dashamooladi Yamaka Sneha and Shuddha Bala Taila Nasya in the Management of Cervicle Radiculopathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh dodiya 
Designation  PG SCHOLAR 
Affiliation  datta meghe institue of medical sciences 
Address  room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha
room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha
Wardha
MAHARASHTRA
442001
India 
Phone  7259177518  
Fax    
Email  dodiyamahesh004@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh dodiya 
Designation  PG SCHOLAR 
Affiliation  datta meghe institue of medical sciences 
Address  room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha
room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha

MAHARASHTRA
442001
India 
Phone  7259177518  
Fax    
Email  dodiyamahesh004@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Parwe 
Designation  Professor 
Affiliation  datta meghe institue of medical sciences 
Address  room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha
room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha
Wardha
MAHARASHTRA
442001
India 
Phone  9403142270  
Fax    
Email  shweta.parwe@dmimsu.edu.in  
 
Source of Monetary or Material Support  
mahatma gandhi ayueved college hospital and research centre hirapur salod wardha 
 
Primary Sponsor  
Name  mahatma gandhi ayurved college hospital and research centre hirapur salod wardha  
Address  room no 40 department of panchakarma mahatma gandhi ayueved college hospital and research centre hirapur salod wardha 
Type of Sponsor  Research institution and hospital 
 
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 Mahesh Dodiya  Mahatma Gandhi Ayurved College Hospital and Research Centre  Room no 40 department of panchakarma
Wardha
MAHARASHTRA 		 7259177518

dodiyamahesh004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
mahatma gandhi ayurved college hospital and research centre institutional ethics committee salod wardha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G320||Subacute combined degeneration ofspinal cord in diseases classified elsewhere. Ayurveda Condition: vishwachi,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: DASHAMOOLADI YAMAKA SNEHA, Reference: BHAISHAJYA RATNAVALI 26TH CHAPTER 28TH SHLOKA, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: FOLLOW UP ON 8TH DAY
2Comparator ArmDrugClassical(1) Medicine Name: SHUDDHABALA TAILA, Reference: Ramya VR, Devakrishnan K. A CLINICAL STUDY ON EFFECT OF SNEHANA NASYA IN VISHWACHI WSR TO CERVICAL SPONDYLOSIS. International Journal of Ayurveda and Pharma Research. 2019 Sep 25:28-37., Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: FOLLOW UP ON 8TH DAY
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either genders having Age group of 21 to 60 years
Patients with cervical radiculopathy whose diagnosis done based on clinical features example Symptoms of Radiating pain from shoulder joint to Arm and tingling sensation and numbness
Patients with decreased ROM of Neck region
Patients fit for Nasyakarma
Patients ready to give inform consent and abide instruction
 
 
ExclusionCriteria 
Details  Patients with Cervical radiculopathy having diabetes mellitus
Post operated cases of cervical radiculopathy
Cervical radiculopathy indicated for surgery
Traumatic cervical radiculopathy
Congenital spine deformity
Carpal tunnel syndrome
Patients with implanted cardiac defibrillator or pace maker
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to assess the efficacy of dashamooladi yamaka sneha nasya in pain neck disability index and range of motion of neck  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the efficacy of shuddhabala taila nasya in pain neck disability index and range of motion of neck  1 week 
 
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)   02/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/05/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 07-08-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a parallel group, randomized, open clinical, standard controlled trial. it will include a 7 days treatment period and at 8th day follow up period 
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