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CTRI Number  CTRI/2025/11/096899 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to check association between patients with clot in deep veins and blood uric acid levels. 
Scientific Title of Study   Clinical Profile of Deep vein Thrombosis Patients and association between deep vein thrombosis and serum uric acid levels. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aryan Jain 
Designation  Junior Resident  
Affiliation  Kasturba Medical College , Manipal Academy of Higher Education 
Address  Department of Medicine , Kasturba Medical College , Madhav Nagar , Manipal , Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9820317438  
Fax    
Email  aryanjain9929@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr BA Shastry 
Designation  Professor of Medicine  
Affiliation  Kasturba Medical College , Manipal Academy of Higher Education 
Address  Department of Medicine , Kasturba Medical College , Madhav Nagar , Manipal , Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845702450  
Fax    
Email  shastryba@yahoo.com.in  
 
Details of Contact Person
Public Query  
Name  Dr BA Shastry 
Designation  Professor of Medicine  
Affiliation  Kasturba Medical College , Manipal Academy of Higher Education 
Address  Department of Medicine , Kasturba Medical College , Madhav Nagar , Manipal , Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845702450  
Fax    
Email  shastryba@yahoo.com.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Aryan Jain 
Address  Department of Medicine , Kasturba Medical College ,Madhav Nagar, Udupi, Manipal, Karnataka, 576104 
Type of Sponsor  Other [Self] 
 
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 
Aryan Jain  Kasturba Medical College  Medicine OPD -Room A, Department of General Medicine, OPD building ,second floor Madhav Nagar, Manipal, Udupi, 576104
Udupi
KARNATAKA 		 9820317438

aryanjain9929@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , Kasturba Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I829||Embolism and thrombosis of unspecified vein,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult males and females presenting with clinical signs and symptoms of deep vein thrombosis
Diagnosed deep vein thrombosis with lower limb USG/ venography
Clinical symptoms of pulmonary thromboembolism
Pulmonary thromboembolism findings on CT Pulmonary angiography or ECG or 2D ECHO 
 
ExclusionCriteria 
Details  Pregnant women
Patients already on anti hyperuricemic drugs 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the clinical profile of Deep vein thrombosis  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To study association between deep vein thrombosis and serum uric acid levels  Serum uric acid levels checked once on diagnosis 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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)   15/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This prospective cross-sectional study titled “Clinical Profile of Deep Vein Thrombosis Patients and Association Between Deep Vein Thrombosis and Serum Uric Acid Levels” aims to evaluate the clinical characteristics of patients with Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) and to determine the association between serum uric acid levels and the development of these conditions. Conducted in the Department of Medicine, KMC Manipal, over a period extending to September 2027 with a sample size of 68, the study will include adults diagnosed with DVT or PE and exclude pregnant women or those on uric acid–lowering therapy. Diagnosis will be made using clinical evaluation and investigations such as Doppler studies and CT pulmonary angiography. Serum uric acid levels will be measured, and statistical analysis using SPSS v23 will explore correlations between biochemical and clinical parameters. Ethical clearance and informed consent will be obtained, with minimal risk limited to blood collection. The findings aim to identify serum uric acid as a potentially modifiable risk factor for thromboembolic disease, contributing to better prevention and management strategies.

 
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