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CTRI Number  CTRI/2024/07/071181 [Registered on: 24/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   A Survey Study To Assess Deha Prakriti In Relation To Osteoarthritis. 
Scientific Title of Study   A Conceptual And Observational Study To Assess Deha Prakriti In Relation To Sandhigatavata (Osteoarthritis). 
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 Kriti Joshi 
Designation  MD Scholar 
Affiliation  Shri NPA Government Ayurved College Raipur,Chattisgarh,India. 
Address  Department of Samhita Evum Siddhant Shri NPA Government Ayurved College , Raipur ,Chattisgarh, India. 492010 OPD no- 2,9 Speciality Clinic - 1,2

Raipur
CHHATTISGARH
492010
India 
Phone  8755959185  
Fax  0  
Email  drkriti14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. L.C.Harjpal  
Designation  HOD Professor MD Ayurveda  
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chattisgarh India. 
Address  Department of Samhita Evum Siddhant Shri Narayan Prasad Awasthi Government Ayurved College, Raipur Chattisgarh. India 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9425215315  
Fax  0  
Email  harjpallalchand@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Shweta Singh 
Designation  Lecturer Samhita Siddhant 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chattisgarh India 
Address  Department of Samhita Evum Siddhant Shri Narayan Prasad Awasthi Government Ayurved College, Raipur Chattisgarh. India 492010

Raipur
CHHATTISGARH
492010
India 
Phone  7999517699  
Fax  0  
Email  drshwetasingh05@gmail.com  
 
Source of Monetary or Material Support  
Shri Narayan Prasad Awasthi Government Ayurved College,Raipur,Chattisgarh,India. 492001 
 
Primary Sponsor  
Name  Principal Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chattisgarh India 
Address  Department of Samhita Evum Siddhant. Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chattisgarh India 492010 
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 Kriti Joshi  Shri Narayan Prasad Awasthi Government Ayurved College and Hospital Raipur Chattisgarh India 492010  OPD no. - 2,9 and Speciality Clinic - 1,2 of GAC Hospital Raipur Chattisgarh
Raipur
CHHATTISGARH 		 8755959185
0
drkriti14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Principal Shri NPA Government Ayurved College,Raipur,Chattisgarh India 492010.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M190||Primary osteoarthritis of other joints. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Already Diagnosed Sandhivata Patients will be included.
Subjects willing for study .
Patients of Primary Osteoarthritis. 
 
ExclusionCriteria 
Details  Patients below 40 years and above 70 years.
Subjects with any Critical Disease, Infectious Disease,Psychological problem,Psoriatic Arthritis,Rheumatoid Arthritis. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine relationship of Prakriti with the severity of Sandhivata.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To achieve social awareness about the effect of Prakriti in general population of Sandhivata and its prevention.  1 year  
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   05/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/08/2024 
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 - NO
Brief Summary   INTRODUCTION 
According to Ayurveda body physiology is maintained by three Doshas i.e Vata,Pitta,Kapha. Doshika predominance at the time of union of male and female gamete forms Prakriti of an individual. Predominant Doshas affect the anatomy , physiology, psychology,immunity of that person. Not only in mainitaining health of an individual it also has an impact on pathogenesis, diagnosis, prognosis and management of the illness. Due to the modern lifestyle involves unhealthy diet, irregular eating and sleeping patterns all fasctors aggravate Vata and leads to kshyaya of dhatu. Sandhivata is one among the disease in which dhatukshyaya takes place .The manifestations of Sandhivata closely resembles with Osteoarthritis .

NEED OF STUDY
Sandhivata is one of the challenging disease due to its chronicity, incurability and complications (Kashtasadhya vyadhi) which affects quality of life of an individual.
 
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