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CTRI Number  CTRI/2018/03/012695 [Registered on: 21/03/2018] Trial Registered Retrospectively
Last Modified On: 11/03/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study on development of cost-effective disease diagnosis technology 
Scientific Title of Study   Development and validation of indigenously developed mobile-Health diagnostic devices for real-time quantification of: Cardiac Troponin T, Lp-PLA2, Glucose, Insulin, HIV p24 antigen, Triiodothyronine, Thyroxine and Thyroid-Stimulating Hormone 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sai Sathish Ramamurthy 
Designation  Assistant Professor, DBT-Ramalingaswami Fellow 
Affiliation  Sri Sathya Sai Institute of Higher Learning 
Address  Department of Chemistry Sri Sathya Sai Institute of Higher Learning Prasanthi Nilayam campus, Puttaparthi, Anantapur District

Anantapur
ANDHRA PRADESH
515134
India 
Phone  8790314405  
Fax  08790314405  
Email  rsaisathish@sssihl.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sai Sathish Ramamurthy 
Designation  Assistant Professor, DBT-Ramalingaswami Fellow 
Affiliation  Sri Sathya Sai Institute of Higher Learning 
Address  Department of Chemistry Sri Sathya Sai Institute of Higher Learning Prasanthi Nilayam campus, Puttaparthi, Anantapur District

Anantapur
ANDHRA PRADESH
515134
India 
Phone  8790314405  
Fax  08790314405  
Email  rsaisathish@sssihl.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sai Sathish Ramamurthy 
Designation  Assistant Professor, DBT-Ramalingaswami Fellow 
Affiliation  Sri Sathya Sai Institute of Higher Learning 
Address  Department of Chemistry Sri Sathya Sai Institute of Higher Learning Prasanthi Nilayam campus, Puttaparthi, Anantapur District

Anantapur
ANDHRA PRADESH
515134
India 
Phone  8790314405  
Fax  08790314405  
Email  rsaisathish@sssihl.edu.in  
 
Source of Monetary or Material Support  
Sri Sathya Sai Institute of Higher Learning (Deemed to be University), Vidyagiri, Prasanthi Nilayam - 515 134 Anantapur Dist., Andhra Pradesh 
Tata Education and Development Trust c/o. Sri Ratan Tata Trust, Bombay House, Homi Mody Street, Fort, Mumbai 400001, Tel.: 022-6665 8282 Fax: 022-6665 8013  
 
Primary Sponsor  
Name  Sri Sathya Sai Institute of Higher Learning 
Address  Vidyagiri, Prasanthi Nilayam Puttaparthi - 515134 Anantapur District, Andhra Pradesh 
Type of Sponsor  Other [Academic Institution (Deemed to be University)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gautam Rege  Sri Sathya Sai Institute of Higher Medical Sciences  Room No. 9, Department of Cardiology, SSSIHMS, Prasanthi Gram, Puttaparthi 515134
Anantapur
ANDHRA PRADESH 		 9890787417

gautam.rege@sssihms.org.in 
Dr Narsimhan  Sri Sathya Sai Mobile Hospital  N-2, B-2, Prasanthi Nilayam, Puttaparthi, Anantapur District Andhra Pradesh – 515134
Anantapur
ANDHRA PRADESH 		 9963051789

sssmhdir@sssmt.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning  Approved 
Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with thyroid symptoms in fluoride endemic areas. Patients with acute coronary syndrome (ACS). ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with known or suspected thyroid abnormalities and skeletal fluorosis.

For the patients with acute coronary syndrome, inclusion age is 18 and above, both males and females. 
 
ExclusionCriteria 
Details  Patients below the age of 6 years and pregnant woman are excluded for thyroid study. Patients identified with Hashimoto thyroiditis will also be excluded from the thyroid study.

For heart study, patients with renal failure will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Understand thyroid dysfunction in fluoride endemic areas.
Understand nexus between depression and cardiac function.
 		 For thyroid study, from the date of enrollment, sampling will be done once every 3 months, four times during the year.

For the heart study, sampling will be done four times - at the time of admission, at discharge, 1st and 6th month after the medical intervention.  
 
Secondary Outcome  
Outcome  TimePoints 
Hand-held device for disease diagnosis  4 years 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   02/12/2017 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The present study would lead to a better understanding of Hypo/hyperthyroidism, especially in fluoride endemic areas, assess clinical outcomes for patients with ACS thus facilitating early diagnosis and management of these diseases.  We also intend to develop a portable, hand-held medical diagnostic device that will be capable of diagnosis of these diseases. 
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