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CTRI Number  CTRI/2021/03/031847 [Registered on: 09/03/2021] Trial Registered Prospectively
Last Modified On: 22/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Tongue Examination in Bone and Joint Disorders with Disease related to Bone Marrow 
Scientific Title of Study   An Observational Survey Study Of Jihva Pariksha in Asthivaha Evum Majjavaha Srotodushti Vikara 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gaurav Malviya 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurved 
Address  PG and Phd Department of Roga Nidan Evum Vikruti Vigyan, Parul Institute of Ayurved, Parul University, Limda Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9584829807  
Fax    
Email  190202209005@paruluniversity.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep G Dahilekar 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  PG and Phd Department of Roga Nidan Evum Vikruti Vigyan, Parul Institute of Ayurved, Parul University, Limda Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9420090584  
Fax    
Email  sandeep.dahilekar260086@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep G Dahilekar 
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  PG and Phd Department of Roga Nidan Evum Vikruti Vigyan, Parul Institute of Ayurved, Parul University, Limda Vadodara


GUJARAT
391760
India 
Phone  9420090584  
Fax    
Email  sandeep.dahilekar260086@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Parul University, Limda - 391760, Vadodara, Gujarat  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gaurav Malviya  Parul Ayurved Hospital  Kayachikitsa OPD No. 116, Parul University, Limda - 391760
Vadodara
GUJARAT 		 9584829807

190202209005@paruluniversity.ac.in 
Dr Gaurav Malviya  Parul Ayurved Hospital  Panchkarma OPD No. 105, Parul University, Limda - 391760
Vadodara
GUJARAT 		 9584829807

190202209005@paruluniversity.ac.in 
Dr Gaurav Malviya  Parul Institute of Ayurved  PG and Phd Department of Roga Nidan Evum Vikruti Vigyan, Parul Institute of Ayurved, Parul University, Limda Vadodara
Vadodara
GUJARAT 		 9584829807

190202209005@paruluniversity.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIA-IECHR  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: ASTHIVAHASROTADUSHTIH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients irrespective of their gender, occupation, religion, socio-economic status will be selected.
2. Patients under the lakshana of Asthivaha and Majjavaha Srotodusti vikara
 
 
ExclusionCriteria 
Details  1. Patients with local tongue infection and congenital anomalies will be excluded.
2. Patient having major ailments of other systems
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe changes in jihva in Asthivaha and Majjavaha Srotodusti Janya Vikara  18 Months 
 
Secondary Outcome  
Outcome  TimePoints 
As this is an observational study and i am observing only changes in Asthivaha and Majjavaha Srotodusti Janya Vikara  18 Months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   15/03/2021 
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   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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [190202209005@paruluniversity.ac.in].

  6. For how long will this data be available start date provided 04-02-2023 and end date provided 04-02-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

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

1. Very few previous work has been done till today regarding the study of Jihva Pariksha in Asthivaha Evum Majjavaha Srotodusti Janya Vikara. Therefore it would be my humble effort to go through this topic and gain maximum authentic information while studying this topic.

2.  By examining the tongue, one can infer not only the state of Doshas, but certain conditions about the tissues and the organs also, along with presence of Ama.

3.  This study will give us the knowledge about the Jihva Pariksha

HYPOTHESIS:

1.     NULL HYPOTHESIS (H0):- There is no relation between Jihva Pariksha and Asthivaha Evum Majjavaha Srotodusti vikara.

2.  ALTERNATE HYPOTHESIS (H1):- There is relation between Jihva Pariksha and Asthivaha Evum Majjavaha Srotodusti vikara.

 
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