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CTRI Number  CTRI/2021/02/031372 [Registered on: 17/02/2021] Trial Registered Prospectively
Last Modified On: 20/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Clinical study of Wild and Cultivated Varieties of Ashwagandha for Grivastambha. 
Scientific Title of Study   Comparative Assessment of Ayurvedic Properties among the Cultivated Varieties of Ashwagandha (Withania somnifera Dunal) along with their Clinical Evaluation in Grivastambha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinita Anilkumar Khatri 
Designation  M.D. Scholar 2nd year  
Affiliation  Government Ayurved College, Vadodara 
Address  Post graduate department of Dravyaguna
Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India 
Phone  8487012556  
Fax    
Email  vinitakhatri31@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dilip K Jani 
Designation  H.O.D. and Professor 
Affiliation  Government Ayurved College, Vadodara 
Address  Post graduate department of Dravyaguna
Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India 
Phone  9925941861  
Fax    
Email  drdilipjn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman Singh 
Designation  Assistant Professor 
Affiliation  Government Ayurved College, Vadodara 
Address  Post graduate department of Dravyaguna
Government Ayurved College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India 
Phone  9510172204  
Fax    
Email  snghsmn@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved College and Hospital,Ajwa road, Dhanvantari marg, Panigate, Vadodara-390019 
 
Primary Sponsor  
Name  Government Ayurved Hospital Vadodara 
Address  Government Ayurved Hospital, Ajwa road,Dhanvantari Marg, Panigate, Vadodara-390019 
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 Vinita A Khatri  Government Ayurved Hospital, Vadodara  OPD and IPD, Dravyaguna Department
Vadodara
GUJARAT 		 8487012556

vinitakhatri31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Gujarat Anand Ashwagandha-1  Sukshma churna of Ashwagandha applied with lukewarm water on affected part(back of neck) as a lepa of 5-7 mm thickness following katu taila abhyanga,Twice a day FOR 14 days 
Comparator Agent  Jawahar Asgand-134  Sukshma churna of Ashwagandha applied with lukewarm water on affected part(back of neck) as a lepa of 5-7 mm thickness following katu taila abhyanga,Twice a day FOR 14 days 
Comparator Agent  Nagori Ashwagandha  Sukshma churna of Ashwagandha applied with lukewarm water on affected part(back of neck) as a lepa of 5-7 mm thickness following katu taila abhyanga,Twice a day FOR 14 days 
Intervention  Wild Ashwagandha (WITHANIA SOMNIFERA DUNAL)  Sukshma churna of Ashwagandha applied with lukewarm water on affected part(back of neck) as a lepa of 5-7 mm thickness following katu taila abhyanga,Twice a day FOR 14 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Clinical symptoms of Grivastambha with or without radiological changes.
Pain in the neck
Stiffness of neck
Difficulty in neck movements (Minimum 3 symptoms)
Symptomatology of Grivastambha (cervical spondylosis) for more than 3 months or in recurrent phase 
 
ExclusionCriteria 
Details  <25 Years or >50 Years
Any acute/ infectious disease
Chronic disease (SLE, rheumatoid diseases, ankylosing spondilitis)
Stenosis of the spinal canal
Fibrositis
Unwilling to participate in the trial. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the Classical Symptoms of Grivastambha  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Difference in Clinical efficacy of Cultivated Medicinal Plants Varieties  21 Days 
 
Target Sample Size   Total Sample Size="6"
Sample Size from India="6" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This study was randomized clinical trial to evaluate and compare the effects of different varieties of Ashwagandha (Withania somnifera Dunal) in Grivastambha. Total 28 patients were enrolled in 4 groups on the basis of computer-generated randomisation. From those, 24 patients had completed study. In this study powder of four varieties of Ashwagandha was applied with lukewarm water on affected part as a Lepa following Katu Taila Abhyanga twice in a day for 14 days. All four varieties of Ashwagandha showed statistically significant difference in various symptoms after treatment. Any ADR was not observed. Highest overall effect of therapy (68.67%) was achieved through Gujarat Anand Ashwagandha-1, while lowest in Nagori Ashwagandha (42.26%). Though, any statistically significant difference was not found among all four varieties of Ashwagandha. Thus, primary outcome that Ashwagandha is effective on Grivastambha was achieved. Along with that secondary outcome was also achieved as difference in clinical efficacy of all four varieties of Ashwagandha on Grivastambha.


 
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