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CTRI Number  CTRI/2017/12/010763 [Registered on: 05/12/2017] Trial Registered Prospectively
Last Modified On: 22/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect and safety of hydroxycholoroquine and atorvastatin in patient suffering from high cholesterol and pre diabetes 
Scientific Title of Study   Efficacy and Safety of hydroxycholorquine and atorvastatin combination in prevention of diabetes in patients with dyslipidemia and pre diabetes: A double blind, randomized comparison with atovastatin alone  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Ipca/HQAT/PIII-15, Version 2.0 dated 16/02/2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anil Pareek 
Designation  President 
Affiliation  Ipca Laboratories Ltd. 
Address  Medical Affairs and Clinical Research Department, 2nd floor, Plot No 142-AB, Kandivli Industrial Estate, Kandivli West,Mumbai

Mumbai
MAHARASHTRA
400067
India 
Phone  02266474641  
Fax  02266474579  
Email  anil.pareek@ipca.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Pareek 
Designation  President 
Affiliation  Ipca Laboratories Ltd. 
Address  Medical Affairs and Clinical Research Department, 2nd floor, Plot No 142-AB, Kandivli Industrial Estate, Kandivli West,Mumbai

Mumbai
MAHARASHTRA
400067
India 
Phone  02266474641  
Fax  02266474579  
Email  anil.pareek@ipca.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Ravi Mehta 
Designation   
Affiliation  Ipca Laboratories Ltd. 
Address  Clinical Research and Development Department, 2nd floor, Plot No 142-AB, Kandivli Industrial Estate, Kandivli West, Mumbai

Mumbai
MAHARASHTRA
400067
India 
Phone  02266474623  
Fax  02266474579  
Email  ravi.mehta@ipca.com  
 
Source of Monetary or Material Support  
Ipca Laboratories Ltd., 142-AB, Kandivli Industrial Estate, Kandivli West, Mumbai 400067, India 
 
Primary Sponsor  
Name  Ipca Laboratories Ltd 
Address  Clinical Research and Development Department, Plot 142-AB, Kandivli Industrial Estate, kandivli West, Mumbai 400067 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 31  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arthur Joseph Asirvatham   Arthur Asirvatham Hospital  42A, Kuruvikaran Salai, Anna Bus Stand, Madurai-625020, Tamil Nadu.
Madurai
TAMIL NADU 		 9443757977

ajasirvathamresearch@yahoo.in 
Dr Md Sabah Siddiqui   All India Institute of Medical Sciences  Assistant Professor, Department of Medicine, All India Institute of Medical Sciences, Tatibandh, G E Road, Raipur -492099, Chhattisgarh.
Raipur
CHHATTISGARH 		 08518881911

dr.sabahsiddiqui@gmail.com 
Dr Vasudha V Sardesai  B.J. Government Medical College and Sassoon General Hospitals  Associate Professor, Department of Medicine, B.J. Government Medical College and Sassoon General Hospitals, Jai Prakash Narayan Road, Near Pune Railway Station, Pune – 411001, Maharashtra
Pune
MAHARASHTRA 		 9822074378

drvasudhsardesai@gmail.com 
Dr Sudhir Bhandari   Bhandari Clinic & Research Centre  Consultant Physician & Diabetologist, Bhandari Clinic & Research Centre, D-126, Krishna Marg, Bapu Nagar, Jaipur-302015, Rajasthan.
Jaipur
RAJASTHAN 		 09829078844

dr.bhandaricr@gmail.com 
Dr Bhavana Sosale  Diacon Hospital (Diabetes Care and Research Centre)   Patient consultation room, ground floor,Department of Diabetes,Diacon Hospital (Diabetes Care and Research Centre),359-360,19th Main 1st Block, Rajajinagar, Bangalore-560010
Bangalore
KARNATAKA 		 9449478512

bhavanasosale@gmail.com 
Dr Swapnav Borthakur  Down Town Hospital  Consultant, Department of Medicine Down Town Hospital, G.S.Road, Dispur, Guwahati-781006, Assam
Kamrup
ASSAM 		 9864038704

swapnav.borthakur@gmail.com 
Dr Trupti Shah  Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre  Consultant, Department of Medicine, Dr. Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre, Ahmedabad-380007, Gujarat.
Ahmadabad
GUJARAT 		 09824083543

trupti2310@gmail.com 
Dr Parul Bhatt  GMERS Medical College and Civil Hospital, Sola  Department of Medicine, Sola, Near Gujarat high court, S.G. Highway, Sola, Ahmedabad- 380060, Gujarat
Ahmadabad
GUJARAT 		 9879599595

parulbhatt30@yahoo.com 
Dr Himanshu Rana  GMERS Medical College and General Hospital, Gotri, Vadodara  Hospital building second floor, OPD room no. 203, Department of Medicine, Gotri Main Road, Gotri, Vadodara-390021
Vadodara
GUJARAT 		 9824036537

drhimanshurana@yahoo.com 
Dr M V Sonavani  Government Medical College, Aurangabad  First floor, Room no 130 Deaprtment of Medicine,Panchakki Road, Aurangabad,431001
Aurangabad
MAHARASHTRA 		 9975136850

kargalman@gmail.com 
Dr Damodar Shenoy  Kasturba Medical College  Professor, Department of Medicine, Kasturba Medical College, Attavar, Mangalore-575001, Karnataka.
Dakshina Kannada
KARNATAKA 		 09845145717

drshenoy2001@hotmail.com 
Dr Yogitha C  Kempegowda Institute of Medical Sciences  Associate Professor, Department of Medicine, Kempegowda Institute of Medical Sciences, Banashankari, 2nd stage, K. R. Road, V. V. Puram, Bangalore-560070, Karnataka.
Bangalore
KARNATAKA 		 09448854442

sunita.mtpatil@rediffmail.com 
Dr Madhukar Mittal   King Georges Medical University   Department of Medical Endocrinology, Chawk, Lucknow-226003
Lucknow
UTTAR PRADESH 		 09956935859

mittalspace@gmail.com 
Dr Prasad M R  KLES Dr.Prabhakar Kore Hospital & Medical Research Center   Consultant Cardiologist, Assistant Professor, J.N Medical College KLES Dr.Prabhakar Kore Hospital & Medical Research Center Nehru Nagar, Belagavi -590010 Karnataka
Belgaum
KARNATAKA 		 09243245777

drprasadmr@gmail.com 
Dr P V Rao  Kumudini Devi Diabetes Research Center, Ramdevrao Hospital  Director, Kumudini Devi Diabetes Research Center, Ramdevrao Hospital, Kukatpally, Hyderabad-500072, Telangana
Hyderabad
ANDHRA PRADESH 		 09885051110

raopaturi@gmail.com 
Dr Amol Laxmanrao Dange  Life Point Multispeciality Hospital  Consultant Diabetologist, Life Point Multispeciality Hospital. 145/1. Mumbai Bangalore Highway, Near Sayaji Hotel, Wakad, Pune-411057, Maharashtra
Pune
MAHARASHTRA 		 9823912040

vasudha.lifepointresearch@gmail.com 
Dr Vijay Viswanathan  M.V. Hospital for Diabetes Pvt. Ltd  Head & Chief Diabetologist, M.V. Hospital for Diabetes Pvt. Ltd. No.4, West Madha Church Street, Royapuram, Chennai - 600013, Tamil Nadu
Chennai
TAMIL NADU 		 09840055535

clinicaltrialmvh@gmail.com 
Dr Prashant Prabhakar Udgire  Mahatma Gandhi Mission Medical College and Hospital  Associate Professor, Department of Cardiology, Mahatma Gandhi Mission Medical College and Hospital, N6, CIDCO, Aurangabad - 431003 Maharashtra
Aurangabad
MAHARASHTRA 		 9503181111

prashant_udgire@rediffmail.com 
Dr Jignesh Vasava  Medical college and SSG hospital  Assistant Professor, Department of Medicine, Medical College and SSG Hospital, Vadodara
Vadodara
GUJARAT 		 09586989650

ssghospital.ct@spearsmind.com 
Dr Manish Agarwal  Medilink Hospital Research Center   Consultant Physician, Medilink Hospital Research Center, Opp. Someshwara Jain Temple, On 132 ft Ring Road, Satellite, Ahmedabad - 380 015.
Ahmadabad
GUJARAT 		 9825443397

medilinkhospital@yahoo.com 
Dr Atul Rajkondawar  Meditrina Institute of Medical Sciences  Consultant Physician & Director Medical Services, Department of Medicine, Meditrina Institute of Medical Sciences, Nagpur – 440012, Maharashtra
Nagpur
MAHARASHTRA 		 9373215775

atul.rajkondawar@gmail.com 
Dr Ramesha SS   Mysore Medical College and Research Institutes  Associate Professor, Department of General Medicine, Mysore Medical College and Research Institutes, KR Hospital, Mysore-570021, Karnataka
Mysore
KARNATAKA 		 9448307060

drssramesh@gmail.com 
Dr CSAnjaneyulu  Neelima Hospitals  Consultant, Neelima Hospitals, 7-2-1735, Sanath Nagar, Hyderabad-500018, Telangana.
Hyderabad
ANDHRA PRADESH 		 9440978535

dcr.neelimahospitals@gmail.com 
DrSubrata Kumar Pal  Nil Ratan Sircar Medical College and Hospital  Professor, Department of Medicine, Nil Ratan Sircar Medical College and Hospital, 138, Acharya Jagadish Chandra Bose Road, Near Railway Station Sealdah, Raja Bazar, Kolkata-700014, West Bengal.
Kolkata
WEST BENGAL 		 09433106630

junigutu@yahoo.com 
DrDNMishra  Nirmal Hospital  Consultant Physician, Department of Medicine,Nirmal Hospital, opposite M.L.B Medical college, Kanpur Road, Jhansi-284128, Uttarpradesh
Jhansi
UTTAR PRADESH 		 09415031689

drmishra.nirmal@gmail.com 
Dr Sudip Chatterjee  Park Clinic  Consultant Endocrinologist, Department of Endocrinology, Park Clinic, 4, Gorky Terrace, Kolkata-700017, West Bengal.
Kolkata
WEST BENGAL 		 09830021170

drsudip.chatterjee@gmail.com 
Dr Veer Bahadur Singh  Sardar Patel Medical College and PBM Hospital  Professor, Department of Medicine, Sardar Patel Medical College and PBM Hospital, Bikaner -334003, Rajasthan.
Bikaner
RAJASTHAN 		 09414136888

vbsingh2@rediffmail.com 
Dr Vivek Arya  Smt. NHL Municipal Medical College  Assistant Professor, Department of Endocrinology, Smt. NHL Municipal Medical College (NHLIEC), VS Hospital Campus, Near Ellisbridge, Ahmedabad -380006, Gujarat.
Ahmadabad
GUJARAT 		 09879537973

vivekarya007@yahoo.com 
Dr Sheetal Vora  Smt. Shardaben Municipal General Hospita  Department of Medicine, Smt. Shardaben Municipal General Hospital, Saraspur, Ahmedabad - 380018, Gujarat.
Ahmadabad
GUJARAT 		 8141128882

shee43@gmail.com 
Dr Indira Pattnaik  Sparsh Hospital  Senior Consultant, Department of Medicine, Sparsh Hospital, A-407, Saheednagar, Bhubaneswar-751007
Khordha
ORISSA 		 9437246066

indirapattnaik@yahoo.co.in 
DrAnurag Agarwal  Vatsalya Maternity & Surgical Center Pvt. Ltd  Consultant, Department of Medicine, Vatsalya Maternity & Surgical Center Pvt. Ltd ,6/8, Elgin Road (Lal Bhadur Shastri Marg), Front of Prayag Sangeet Samiti, Civil Lines, Allahabad -211001, Uttapradesh.
Allahabad
UTTAR PRADESH 		 09415289339

anurag7877@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 34  
Name of Committee  Approval Status 
Diacon Hospital Ethics Committee, Bangalore  Approved 
Ethics Committee N.R.S Medical college Kolkata  Submittted/Under Review 
Ethics Committee, GMERS medical college, Ahmedabad, Gujarat  Submittted/Under Review 
Ethics Committee, JNUIMSRC, Jaipur  Approved 
Ethics Committee, King Georges Medical University, Lucknow  Submittted/Under Review 
Ethics Committee, M.V. Hospital, Diabetes Pvt Ltd, TamilNadu  Submittted/Under Review 
Ethics Committee, N.R.S. Medical College, Kolkata  Submittted/Under Review 
Ethics Committee,S.P.Medical College,Bikaner   Submittted/Under Review 
Insitutional Ethics Committee, G.M.E.R.S Medical College, Sola, Ahmedabad  Submittted/Under Review 
Insitutional Ethics Committee, Government Medical College, Aurangabad  Submittted/Under Review 
Institute Ethics Committee,AIMS,Chhattisgarh  Submittted/Under Review 
Institutional Ethics Committee on Human Research, Medical college Baroda  Submittted/Under Review 
Institutional Ethics Committee, Arthur Asirvatham Hospital  Approved 
Institutional Ethics Committee, B.G Government Medical college and Sasson Government Hospitals, Pune  Submittted/Under Review 
Institutional Ethics Committee, Down Town Hospital, Assam  Submittted/Under Review 
Institutional Ethics Committee, Heritage Hospital, Varanasi,   Submittted/Under Review 
Institutional Ethics Committee, KLE deemed to be university Karnataka  Approved 
Institutional Ethics Committee, Mysore Medical College & Research Institute, Mysore  Approved 
Institutional Ethics Committee, Neelima Hospitals, Telangana  Approved 
Institutional Ethics Committee, Nirmal Hospital Uttar Pradesh  Submittted/Under Review 
Institutional Ethics Committee, Ramdevrao hospital, Hyderabad  Approved 
Institutional Ethics Committee, Smt. NHL Municipal Medical College, Ahmedabad   Submittted/Under Review 
Institutional Ethics Committee, Smt. NHL Municipal Medical College, Ahmedabad   Submittted/Under Review 
Institutional Ethics Committee, Sparsh Hospital, Odisha  Submittted/Under Review 
Institutional Ethics Committee, Vatsalya materninity & surgical pvt ltd, Allahabad  Submittted/Under Review 
Institutional Human Ethics Committee, GMERS Medical College & Hopsital, Gotri, Vadodara  Submittted/Under Review 
KIMS, Institutional Ethics Committee, Banglore  Submittted/Under Review 
Lifepoint Research-Ethics Committee, Wakad, Pune  Approved 
Manipal University Ethics Committee, Karnatka  Submittted/Under Review 
Medilink Ethics Committee,Ahmedabad  Approved 
Meditrina Institute Ethics Committee, Nagpur  Submittted/Under Review 
MGM, Ethics Committee for Research on Human Subjects, Aurangabad  Approved 
Park Clinic Ethics Committee, Kolkata  Submittted/Under Review 
The JMSHF and BMRC Institutional Ethics Committee, Ahmedabad, Gujarat  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R730||Abnormal glucose,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Atorvastatin tablet 20 mg   Pre diabetic patients with dyslipidemia 
Comparator Agent  Hydroxycholoroquine 300 mg with Atorvastatin 20 mg  Pre diabetic patient with dyslipidemia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients with primary dyslipidemia (LDL-C level ≥ 130 mg/dL and/or TG levels ≥150 mg/dL and ≤ 400 mg/dL).
2) Patients having HbA1c between 5.7% and 6.4%
3) Patients with body weight > 60 kg
4) Patients able to understand and willing to fully comply with study procedures and
restrictions
5) Patient ready to give written informed consent as per applicable regulatory
requirements 
 
ExclusionCriteria 
Details  1) Patients with Type 1 or Type 2 diabetes
2) Patients with a history or presence of any retinopathy of any grade including diabetic
retinopathy requiring laser therapy, evidence of an imminent need for retinal laser
therapy, uncorrected visual acuity <20/100, abnormal visual fields, difficulty to
examine optic disc, or evidence of retinal pigment epithelial abnormalities and
patients with history or risk of macular edema
3) Patients with abnormal renal function (eGFR <60 mL/min/1.73m2)
4) Patients with abnormal liver function (AST and ALT, total bilirubin, creatine
phosphokinase or alkaline phosphatase >2.5 times the upper limit of normal values)
5) Patients with cardiovascular accident or myocardial infarction, stroke or has
undergone coronary artery bypass surgery, percutaneous transluminal coronary
angioplasty or transient ischemic attack, or history of congestive heart failure, or
unstable angina or edema of any type in past
6) Patients with history of myalgia, aplastic anemia or agranulocytosis,
granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD
deficiency
7) Patient with history of symptomatic autonomic neuropathy
8) Patients with disease of blood or haematopoetic organs or hemoglobin< 11g/dL for
female patient or hemoglobin< 13 g/dL for male patient
9) Patients with systolic BP > 180 mm Hg and/or diastolic BP >110 mmHg
10) Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and
duodenal ulcer)
11) Patient who had any other illness for which hydroxychloroquine was indicated (such
as rheumatoid arthritis, SLE).
12) Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection
13) Patients with any other clinically significant abnormality (ies) interfering with disease under evaluation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Patients developing diabetes (HbA1c ≥ 6.5%)  Within 52 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage change in low-density lipoprotein cholesterol
(LDL-C), total cholesterol (TC), triglycerides (TG), high-density lipoprotein
cholesterol (HDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) 		 At week 24 and week 52 
 
Target Sample Size   Total Sample Size="992"
Sample Size from India="992" 
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   Phase 3 
Date of First Enrollment (India)   01/01/2018 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The primary purpose of this study is to compare the hydroxycholoroquine 300 mg and atorvastatin 20 mg tablet with atorvastatin 20 mg tablet alone in prevention of diabetes in patients with  dylipidemia and pre diabetes.  
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