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CTRI Number  CTRI/2025/07/091766 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Tools for Catching Subclinical Hypothyroidism Early 
Scientific Title of Study   Study OF thyroid hormones and early Predictive Biomarkers in hypothyroidism. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shesharam Patel 
Designation  Assistant Professor 
Affiliation  Govt. Medical College Pali Rajasthan  
Address  Department of Biochemistry Govt. Medical College Pali Rajasthan

Pali
RAJASTHAN
306401
India 
Phone  9799367837  
Fax    
Email  patelshesharal1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Raghvendra Singh 
Designation  Associate Professor 
Affiliation  UPUMS 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE 3rd FLOOR OLD BULDING UPUMS SAIFAI ETAWAH

Etawah
UTTAR PRADESH
206130
India 
Phone  09461008561  
Fax    
Email  dr.raghvendra_singh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Raghvendra Singh 
Designation  Associate Professor 
Affiliation  UPUMS 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE 3rd FLOOR OLD BULDING UPUMS SAIFAI ETAWAH

Etawah
UTTAR PRADESH
206130
India 
Phone  09461008561  
Fax    
Email  dr.raghvendra_singh@yahoo.com  
 
Source of Monetary or Material Support  
Govt. Medical College Pali and Attached Bangur Hospital Pali Rajasthan India pin no 306401 
 
Primary Sponsor  
Name  Shesharam Patel 
Address  Department of Biochemistry 2nd Floor Govt. Medical College Pali and Attached Bangur Hospital Pali Rajasthan India pin no 306401 
Type of Sponsor  Other [yourself] 
 
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 
Sanjay Choudhary  Govt. Medical College and Attached Bangur Hospital Pali  Central Lab Room no 130 Govt. Medical College and Attached Bangur Hospital Pali Rajasthan India
Pali
RAJASTHAN 		 9460191676

sanjay12july74@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMITTEE GOVERNMENT MEDICAL COLLEGE PALI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 13 to 60 years
Normal FT3 and FT4 levels
TSH between 4.5–10 mIU/L (indicative of subclinical hypothyroidism)
 
 
ExclusionCriteria 
Details  Overt hypothyroidism or hyperthyroidism
Current use of thyroid hormone replacement or anti-thyroid drugs
History of major systemic illness (e.g., liver disease, renal disease, malignancy)
Pregnant or lactating women
Patients on corticosteroids or medications affecting thyroid function
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The ability of serum reverse T3 and FT3/FT4 ratio to predict progression from subclinical hypothyroidism to overt hypothyroidism.  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between rT3 & FT3/FT4 ratio with TSH levels & clinical parameters of thyroid dysfunction in SCH patients.  At Baseline 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   18/08/2025 
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="1"
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  

Background

Subclinical hypothyroidism (SCH) is characterized by elevated thyroid-stimulating hormone (TSH) levels with normal free thyroxine (FT4) and free triiodothyronine (FT3). Identifying early biochemical markers that can improve diagnosis, predict progression, or guide treatment decisions is crucial. Serum reverse T3 (rT3), an inactive thyroid hormone metabolite, and the FT3/FT4 ratio may reflect peripheral thyroid hormone metabolism more accurately than conventional parameters.

Aim

To evaluate the diagnostic and predictive utility of serum reverse T3 and the FT3/FT4 ratio in identifying and stratifying subclinical hypothyroidism.

Objectives

  1. Compare serum reverse T3 levels in euthyroid and subclinical hypothyroid individuals.

  2. Calculate and assess FT3/FT4 ratio in both groups.

  3. Evaluate the correlation between rT3 and FT3/FT4 ratio.

  4. Determine the diagnostic sensitivity, specificity, and predictive accuracy of these markers using ROC curve analysis.

  5. Explore their role in enhancing early detection and risk stratification of SCH.

Study Design

  • Type: Analytical, observational, case-control study

  • Groups:

    • Group A: Subclinical hypothyroid patients (TSH > normal, FT4 and FT3 normal)

    • Group B: Age- and sex-matched euthyroid controls

  • Sample Size: 110 participants (55 per group), calculated to ensure power for group comparison and ROC analysis.

Inclusion Criteria

  • Adults aged 18–65 years

  • Newly diagnosed with SCH (for cases)

  • Euthyroid status confirmed within 3 months (for controls)

Exclusion Criteria

  • Overt thyroid disorders

  • Chronic illnesses, pregnancy, or medications affecting thyroid function

  • Recent acute illness

Data Collection & Analysis

  • Measure TSH, FT3, FT4, and reverse T3 using standardized assays

  • Calculate FT3/FT4 ratio

  • Statistical analysis: independent t-tests, correlation analysis, ROC curves (AUC

 
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