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CTRI Number  CTRI/2024/07/070235 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   STANDARDIZATION OF A QUESTIONNAIRE FOR ASTHIWAHA STROTAS PARIKSHA 
Scientific Title of Study   AN OBSERVATIONAL STUDY TO STANDARDIZE A QUESTIONNAIRE FOR ASTHIWAHA STROTAS PARIKSHA 
Trial Acronym  DOSQA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shama karekar Bhoir 
Designation  PhD scholar 
Affiliation  YMT Ayurvedic Medical college 
Address  YMT AYURVEDIC MEDICAL COLLEGE , INSTITUNAL AREA ,SECTOR 4 , KHARGHAR , NAVI MUMBAI.

Raigarh
MAHARASHTRA
410210
India 
Phone  8793488139  
Fax    
Email  drmrunalsparsh86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Jai Kiran Kini 
Designation  Associate Professor 
Affiliation  Ymt Ayurvedic Medical college 
Address  YMT AYURVEDIC MEDICAL COLLEGE , INSTITUNAL AREA ,SECTOR 4 , KHARGHAR , NAVI MUMBAI.

Raigarh
MAHARASHTRA
410210
India 
Phone  9869046901  
Fax  27749895  
Email  vd.jaikini@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Shama karekar Bhoir 
Designation  PhD scholar 
Affiliation  Ymt Ayurvedic Medical college 
Address  YMT AYURVEDIC MEDICAL COLLEGE , INSTITUNAL AREA ,SECTOR 4 , KHARGHAR , NAVI MUMBAI.

Raigarh
MAHARASHTRA
410210
India 
Phone  8793488139  
Fax    
Email  drmrunalsparsh86@gmail.com  
 
Source of Monetary or Material Support  
Ymt Ayurvedic Medical college & Hospital, Institutional area Sector 4 , Kharghar, Navi Mumbai 410210 
 
Primary Sponsor  
Name  Shama Karekar Bhoir 
Address  Ymt Ayurvedic Medical college & Hospital, Institutional area Sector 4 , Kharghar, Navi Mumbai 
Type of Sponsor  Other [Self sponsered] 
 
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 Shama Karekar Bhoir  Ymt Ayurvedic Medical college & Hospital  Ymt Ayurvedic Medical college & Hospital- (Ground Floor )Room No.1 OPD of Panchkarma , Room No.2 & Room No. 3 OPD of Shalya,Room No. 9 OPD of Kayachikitsa
Raigarh
MAHARASHTRA 		 8793488139

drmrunalsparsh86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of YMT Ayurvedic Mahavidyalay Navi Mumbai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M159||Polyosteoarthritis, unspecified. Ayurveda Condition: ASTHIVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patients of Asthiwaha stroto vikara irrespective of their gender, Religion, Caste , Occupation , socioeconomic status etc. who can in their full consciousness give clear consent for the project  
 
ExclusionCriteria 
Details  1.Patients with genetic syndromes - Down’s syndrome, Kline filter’s syndrome, Turner’s syndrome.
2.Patients of carcinoma and any other systemic diseases affecting multiple body systems.
3.Pregnant women.
4.Individuals not willing to participate after information of project or who do not give complete response to the questionnaire.
5.Patients diagnosed with Majjawaha strotagat vyadhi as per Ayurvedic classics- Mad, Murccha, Sanyas , Attatvaabhinivesh , Apsmar , Unmad.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To design uniform patterned, sensitive questionnaire & Planning to Distribute Questionnaire to experts for Questionnaire domain evaluation.   18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To design & Standardize a questionnaire for Asthiwaha strotas parikshan  18 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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   The observational study aimed to standardize questionnaires for Asthivaha Srotas Pariksha involved administering various assessment tools to a sample population to evaluate their validity, reliability, and other psychometric properties. Researcher will assess the sensitivity, specificity, concordance, construct validity, and factor structure of the questionnaires to ensure they accurately measure bone tissue health and align with the theoretical framework of Asthivaha Srotas. The study will also examine the acceptability and feasibility of the questionnaires for both participants and healthcare providers. Overall, the findings from this study will provide valuable insights into the development of standardized tools for assessing Asthivaha Srotas Pariksha, enhancing clinical practice and research in bone health assessment. 
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