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CTRI Number  CTRI/2026/01/100766 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Early Thyroid Problems and Their Impact on Blood Cholesterol 
Scientific Title of Study   Assessment of lipid profile in patients of subclinical 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  Avtar Singh Dhanju 
Designation  Professor  
Affiliation  SRI GURU RAM DAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH 
Address  C/o Swaran Singh , house number 306 ,GREEN FIELD AVENUE MAJIITHA ROAD

Amritsar
PUNJAB
143001
India 
Phone  7009067238  
Fax    
Email  avtar.dhanju.ad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Avtar Singh Dhanju 
Designation  Professor  
Affiliation  SRI GURU RAM DAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH 
Address  C/o Swaran Singh , 306 GREEN FIELD AVENUE MAJIITHA ROAD, Amritsar , India

Amritsar
PUNJAB
143001
India 
Phone  7009067238  
Fax    
Email  avtar.dhanju.ad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mridul soni 
Designation  Junior resident  
Affiliation  SRI GURU RAM DAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH 
Address  Sri Guru Ram Das Institute of Medical Sciences,Amritsar , India

Amritsar
PUNJAB
143501
India 
Phone  7807605775  
Fax    
Email  mridulsoni29@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of medicine  
Address  SGRD , VALLAH , AMRITSAR 
Type of Sponsor  Private 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 
Mridul Soni  Sri guru ram Das institute of medical sciences and research  Department of medicine , 3rd floor
Amritsar
PUNJAB 
7807605775

mridulsoni29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Willing to participate  
 
ExclusionCriteria 
Details  Pregnancy
Overt hypothyroidism
Patient part of any other study during this period
Familial hypertriglyceridemia
Patient of oral contraceptives 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Determine if any Relation between sub clinical hypothyroidism and lipid profile,determine if age and sex influence lipid profile in subclinical hypothyrodism  Determine if any Relation between sub clinical hypothyroidism and lipid profile,determine if age and sex influence lipid profile in subclinical hypothyrodism 
 
Secondary Outcome  
Outcome  TimePoints 
Nil   
 
Target Sample Size   Total Sample Size="114"
Sample Size from India="114" 
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)   14/01/2026 
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="6"
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  
Subclinical hypothyroidism is a common thyroid disorder characterized by elevated thyroid-stimulating hormone (TSH) levels with normal circulating thyroid hormone levels. Although often asymptomatic, subclinical hypothyroidism has been associated with metabolic disturbances, particularly abnormalities in lipid profile, which may increase the risk of cardiovascular disease.

This cross-sectional observational study aims to assess the lipid profile in adult patients diagnosed with subclinical hypothyroidism and to evaluate the correlation between serum TSH levels and lipid parameters. Adult patients attending the outpatient and inpatient departments of Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar, will be screened for subclinical hypothyroidism using thyroid function tests. Eligible participants will undergo lipid profile assessment, including total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, VLDL cholesterol, and non-HDL cholesterol.

The study does not involve any experimental intervention or additional cost to the participants. Blood investigations performed are part of routine clinical evaluation. Written informed consent will be obtained from all participants, and confidentiality of patient data will be strictly maintained. The results of this study may help in early identification of dyslipidemia in patients with subclinical hypothyroidism and emphasize the importance of timely management to reduce future cardiovascular risk. 
 
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