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CTRI Number  CTRI/2024/07/070367 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 05/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of Atorvastatin on thyroid eye disease 
Scientific Title of Study   To study the effect of statins on Graves orbitopathy in patients with Graves disease presenting to a tertiary care hospital in Western Maharashtra 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aswin Babu N 
Designation  PG student 
Affiliation  Armed Forces Medical College 
Address  Room No 6/9 Single officers accomodation OSR Armed forces medical college Pune-411040
Departement of Internal Medicine Armed forces medical college Wanowrie, Sholapur road Pune -411040
Pune
MAHARASHTRA
411040
India 
Phone  7767953554  
Fax    
Email  aswinbpalat888@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Brig(Dr) J Muthukrishnan 
Designation  PG Thesis Guide 
Affiliation  Armed Forces Medical College 
Address  Brig(Dr) J Muthukrishnan Prof and HoD Department Of Internal Medicine Armed forces medical college Sholapur Road, Wanowrie Pune-411040

Pune
MAHARASHTRA
411040
India 
Phone  8698951237  
Fax    
Email  jmuthukrishnan@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Aswin Babu N 
Designation  PG student 
Affiliation  Armed Forces Medical College 
Address  Room No 6/9 Single officers accomodation OSR Armed forces medical college Pune-411040
Departement of Internal Medicine Armed forces medical college Wanowrie, Sholapur road Pune -411040
Pune
MAHARASHTRA
411040
India 
Phone  7767953554  
Fax    
Email  aswinbpalat888@gmail.com  
 
Source of Monetary or Material Support  
Department of Internal Medicine, Armed Forces Medical College Sholapur Road, Pune, Maharashtra, India -411040 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Armed Forces Medical College, Pune-411040 
Type of Sponsor  Research institution and hospital 
 
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 Aswin Babu N  Armed Forces Medical College  Room No 1 Dept of Internal Medicine Armed Forces Medical College, Wanowrie, Sholapur road Pune-411040
Pune
MAHARASHTRA 		 7767953554

aswinbpalat888@gmail.com 
Dr Aswin Babu N  Command Hospital Pune  Room No 1 , Department of Internal Medicine Command Hospital Pune-411040 411040
Pune
MAHARASHTRA 		 7767953554

aswinbpalat888@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Armed Forces Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E050||Thyrotoxicosis with diffuse goiter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atorvastatin  Patients will be given Tablet Atorvastatin 20 mg per orally once at night for six months 
Comparator Agent  Methylprednisolone  Patients with Graves orbitopathy will be managed depending on their clinical activity score. Patients with mild disease will be given no drugs. Patients with moderate-severe disease will be given IV Methylprednisolone 500mg/week for 6 weeks followed by 250mg/week for next 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Confirmed diagnosis of graves disease
2. Willingness to give consent 
 
ExclusionCriteria 
Details  1. Previous treatment with statins within the past 6 months.
2. Contraindications to statin therapy.
3. History of other diseases affecting the thyroid or orbit.
4. Pregnancy or lactation.
5. Patients who did not provide informed consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Improvement in clinical activity score   6 months post initiation of statin therapy  
 
Secondary Outcome  
Outcome  TimePoints 
2.Changes in CBC, LFTs, and RFTs from baseline, particularly focusing on any adverse effects related to statin therapy.  6 months post initiation of statin therapy 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) 01/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/12/2025 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

A total of 150 patients diagnosed with Graves’ disease will be enrolled in the study. These 150 patients are then randomly selected and randomised into two equal groups using computer generated random number sequence-The Control group and the Treatment group. All the 150 patients will undergo a baseline clinical examination, laboratory investigations, eye examination and their 7 point Clinical activity score will be calculated. The control group will receive only the standard of care treatment whereas the treatment group will be administered 20mg of Atorvastatin once daily at night for a duration of 6 months in addition to the standard of care treatment. All patients will undergo comprehensive ophthalmologic evaluations to assess features of Graves’ orbitopathy, baseline laboratory investigations and their 10 point Clinical activity score will be calculated at 3months and 6months. Subsequently, the collected data will be analysed to determine the impact of statin therapy on patients with Graves disease.

 
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