CTRI

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CTRI Number

CTRI/2016/02/006599 [Registered on: 02/02/2016] Trial Registered Prospectively

Last Modified On:

30/09/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Single Arm Study

Public Title of Study

A Clinical Trial to Study the Safety and Efficacy of Hydroxychloroquine in Patients with Type-2 Daibetes

Scientific Title of Study

Evaluation of Safety and Efficacy of Hydroxychloroquine Sulfate as an Adjunct to Diet and Exercise to Improve Glycemic Controll in Type-2 Diabetes Patients Uncontrolled on Sulfonylurea and Metformin Combination

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
Ipca/HCQS/Phase-IV Verson no. 2, dated-30/03/2015	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, 142-AB Kandivali Industrial Estate, Kandivali(West), Mumbai Mumbai MAHARASHTRA 400067 India
Phone
Fax
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, 142-AB Kandivali Industrial Estate, Kandivali(West), Mumbai Mumbai MAHARASHTRA 400067 India
Phone
Fax
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, 142-AB Kandivali Industrial Estate, Kandivali(West), Mumbai Mumbai MAHARASHTRA 400067 India
Phone	02266474623
Fax	02266474579
Email	ravi.mehta@ipca.com

Source of Monetary or Material Support

Ipca Laboratories Ltd, Mumbai

Primary Sponsor

Name	Ipca Laboratories Ltd
Address	142-AB, Kandivali Industrial Estate, Kandivali(W), 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 = 66
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Nithish Bhandari	A.J. Institute of Medical Sciences and Research Centre	Ground floor, room no 3, Department of Medicine, A.J.Institute of Medical Sciences and Research Centre,NH-66, Kuntikana, Mangalore-575004 Bangalore KARNATAKA	9448023147 drnithishmd@yahoo.co.in
Dr Ramkrishna Naidu	Andhra Medical College and KG Hospital	First floor OPD Room No 13 Department of Medicine, K.G.Hospital,KGH Down Rd, Jagadamba Area, Maharanipeta, Visakhapatnam-530002 Visakhapatnam ANDHRA PRADESH	9885093386 rammky@yahoo.com
Dr Harshal Bhitkar	B.J. Government Medical College and Sassoon General Hospitals	Department of Medicine, B.J. Government Medical College and Sassoon General Hospitals, Jai Prakash Narayan Road, Near Pune Railway Station, Pune â€“ 411001 Pune MAHARASHTRA	08007874541 harshalbhitkar@gmail.com
Dr Siddhartha Shah	Bhatia Hospital	Ground floor, Room No G2, Department of Endocrinology,Bhatia Hospital, Tardeo Road,Mumbai-400007 Mumbai MAHARASHTRA	9819888500 drsnsonline@gmail.com
Dr Unnikrishnan A G	Chellaram Diabetes Hospital	Lalani Quantum, Pune-Bangalore Express Highway, NH4, Bavdhan Budruk, Pune- 411021,Maharashtra. Pune MAHARASHTRA	08605011934 ceo@cdi.org.in
Dr Sanjiv Indurkar	Diabetic Care and Research Centre	Rachnakar Colony, Station Road, Aurangabad- 431005, Maharashtra. Aurangabad MAHARASHTRA	9823110498 madhumeh.indurkar@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 Parashuram	Dr B R Ambedkar Medical College	Department of Medicine, Dr B R Ambedkar Medical College, Kadugondanahalli, Bangalore-560045 Bangalore KARNATAKA	09986311450 drbhavimani@gmail.com
Dr R Srinivasan	G Kuppuswamy Naidu Memorial Hospital	Department of Endocrinology, G. Kuppuswamy Naidu Memorial Hospital, P. B. No. 6327, Nethaji Road, Pappanaickenpalayam, Coimbatore â€“ 641 037 Coimbatore TAMIL NADU	09600933080 srinir02@gmail.com
Dr Richa Giri	Ganesh Shankar Vidhyarthi Memorial Medical College	Swaroop Nagar, Kanpur, Uttar Pradesh 208002 Kanpur Nagar UTTAR PRADESH	08400331045 drrichagiri.gsvm@gmail.com
Dr Lalit Shrimali	Geetanjali Medical College and Hospital,	First floor, Room no 138,Department of Medicine,Geetanjali Medical College and Hospital, NH-8 Bypass, Eklingpura chouraha,Udaipur,-313002 Udaipur RAJASTHAN	9414166465 drlalitshrimali@yahoo.co.in
Dr Himashu Rana	GMERS Medical College and Hospital	Hospital building second floor OPD room no. 203, Department of Medicine, GMERS Medical College and Hospital,Gotri Main Road, Gotri, Vadodara-390021 Vadodara GUJARAT	9824036537 drhimanshurana@yahoo.com
Dr Parul Bhatt	GMERS Medical College and Hospital	Department of Medicine, GMERS Medical College and Hospital, Sola, S. G. Highway, Ahmedabad, Gujarat â€“ 380061 Ahmadabad GUJARAT	9879599595 parulbhatt30@yahoo.com
Dr Shashi Kumar Mundhra	GMERS Medical College and Hospital	First floor room no. 104, Department of Medicine, GMERS Medical College and Hospital, Pathikashram, Sector-12, Gandhinagar Gandhinagar GUJARAT	9426702689 drshashimundhra@yahoo.co.in
Dr Milind Vyawahare	Government Medical College	Hanuman Nagar, Nagpur-440009, Maharashtra. Nagpur MAHARASHTRA	9822234566 drmilind72@gmail.com
Dr MV Sonavani Borkar	Government Medical College	First floor Room no 130 Deaprtment of Medicine, Government Medical College,Panchakki Road, Aurangabad,431001 Aurangabad MAHARASHTRA	9975136850 kargalman@gmail.com
Dr Sunil J Panjwani	Government Medical College	Ground floor Room no 63,Department of Medicine, Government Medical College,Near State Road Transport Corporation Bus Stand, Bhavnagar-364001 Bhavnagar GUJARAT	9825331039 spanjwani0@gmail.com
Dr B S Bal	Government Medical College and Hospital	First floor, Room no 11 Deaprtment of Medicine,Government Medical College and G.N.D. Hospital,Circular Road, Amritsar-143001 Amritsar PUNJAB	8146522864 drbalbs@gmail.com
Dr Mahesh Solu	Government Medical College and New Civil Hospital	Ground floor, Room No 12, Department of Medicne, Government Medical College and New Civil Hospital,Out side Majura gate, Surat-395001 Surat GUJARAT	9825233273 drmaheshgsolu@yahoo.in
Dr NK Thulaseedharan	Government Medical College,Kozhicode	Ground Floor,OPD Room No 15 Department of Medicine, Government Medical College,Medical College Road, Government Medical College Campus,Kozhicode, Kerala 673008 Kozhikode KERALA	9847955875 dr_thulasidharan@yahoo.com
Dr Ghanshyam Goyal	ILS Hospital	Second floor, Clinical trial room and Department of Medicine,ILS Hospital,DD-6,Jeevansatya, sector-1,Salt Lake City,Kolkata-700064 Kolkata WEST BENGAL	9830400450 drgsgoyal@hotmail.com
Dr P K Jabbar	Indian Institute of Diabetes	Indian Institute of Diabetes, Pulayanarkotta,Thiruvannathapuram-695031, Kerala Thiruvananthapuram KERALA	09446828766 drjabbar10@gmail.com
Dr Rajashree Khot	Indira Gandhi Government Medical College	Ground floor, room no 15, Department of Medicine,Indira Gandhi Government Medical College,C.A. Road, Nagpur-440018 Nagpur MAHARASHTRA	09823134598 rajashree.s.khot@gmail.com
Dr Rajiv Raina	Indira Gandhi Medical College	4th Floor OPD 511-2E B Block Department of Medicine,IGMC, Circular Road,Lakkar Bazar,Shimla-171001 Shimla HIMACHAL PRADESH	9418452815 rajivrainaigmc@gmail.com
Dr Kishore Chandra Mahanta	Ispat General Hospital	Department of Medicine, Ispat General Hospital, Rourkela, Sundergarh, Odisha-769 005 Sundargarh ORISSA	08895501182 kishoremalaria@rediffmail.com
Dr Ashok Dutt Mathur	Jaipur National University, Institute of Medical Sciences and Research Center, Jaipur	Jaipur National University, Institute of Medical Sciences and Research Center,Jagatpura,Jaipur- 302017 Jaipur RAJASTHAN	8696903400 clinicalresearch@jnuhealthcare.com
Dr Ramrajan S	Karpagam Faculty of Medical Sciences and Research	Ground floor, Room no E-106, Department of Medicine, Othakkalmandapam,NH 47, Coimbatore-641032 Coimbatore TAMIL NADU	09677179441 skramarajan@gmail.com
Dr V Channaraya	Kempegowda Institute Of Medical Sciences (KIMS) Hospital	Department of Medicine, Kempegowda Institute Of Medical Sciences (KIMS) Hospital, K R Road, VV Puram, Bangalore- 560004 Bangalore KARNATAKA	09341234049 vcraya@yahoo.com
Dr Raj Mohan L	Kerala Institute of Medical Sciences	Fourth floor, room no 2406,Department of Endocrinology,Kerala Institute of Medical Sciences, P.B.No.1,Anayara,Thiruvanathapuram,Kerala-695029 Thiruvananthapuram KERALA	8714808542 dr_rajmohan@hotmail.com
Dr Madhukar Mittal	King Georges Medical University	Endocrinology Unit, Department of Internal Medicine, King Georgeâ€™s Medical University (Erstwhile Chhatrapati Shahuji Maharaj Medical University), Chawk, Lucknow-226003 Lucknow UTTAR PRADESH	09956935859 mittalspace@gmail.com
Dr Debashish Chaudhury	Lady Hardinge Medical College and Associated Hospitals	Ground floor, Room no B-4 A Department of Medicine, Lady Hardinge Medical College and Associated Hospital, Shivaji Marg, New Delhi-110001 New Delhi DELHI	9868561577 debashishccc@yahoo.com
Dr Sameer Shrikant Yadav	Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College	Department of Medicine, Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Dr. Babasaheb Ambedkar Road, Sion (West), Mumbai â€“ 400022 Mumbai MAHARASHTRA	09820845712 sameer_yadav25@yahoo.com
Dr V Mohan	Madras Diabetes Research Foundation, Chennai	Madras Diabetes Research Foundation,No.4, Conran Smith Road, Gopalapuram, Chennai-600014 Chennai TAMIL NADU	9840134505 drmohans@diabetes.ind.in
Dr Krishna Seshadri	Mahatma Gandhi Medical College and Research Institute, Pondicherry	Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry-607402 Pondicherry PONDICHERRY	9940068170 krishnagseshadri@gmail.com
Dr Ramesh Gupta	Marudhar Hospital	Basement, room no 9,Department of Medicine,Marudhar Hospital,A-93-99, Singh Bhoomi,Khatipura Road,Jaipur-302012 Jaipur RAJASTHAN	9829016373 doc.rkgupta128@gmail.com
Dr Keyur Brahme	Medical College	Department of Medicine, Medical College, Anandpura, Vadodara -390001 Vadodara GUJARAT	09727729105 keyurbrahme@gmail.com
Dr Manish Agarwal	Medilink Hospital Research Center	Department of Cardiology and Diabetology, Medilink Hospital Research Center, Opp. Someshwara Jain Temple, On 132 ft Ring Road, Satellite, Ahmedabad - 380 015. Ahmadabad GUJARAT	9825443397 medilinkhospital@gmail.com
Dr Atul Rajkondawar	Meditrina Institute of Medical Sciences	Ground floor, Room no 10,Department of Medicine,Meditrina Institute of Medical Sciences,278,Central Bazar Road, Ramdaspeth, Nagpur,440012 Nagpur MAHARASHTRA	9373215775 atul.rajakondawar@gmail.com
Dr Vandana Dandekar	MGM Hospital	Department of General Medicine, MGM Hospital, Plot No.1 & 2, NH-4 Junction, Sector-1, Kamothe, Navi Mumbai â€“ 410209 Mumbai (Suburban) MAHARASHTRA	09323292281 vandana.dandekar@gmail.com
Dr SS Ramesha	Mysore Medical College and Research Institute	Ground floor, Room no 1 Department of Medicine, Mysore Medical College and Research Institute, KR Hospital,Near Mysore Railway Station, Irwin Road,Yadavgiri,Mysore-570001 Mysore KARNATAKA	9448307060 drssramesh@gmail.com
Dr Chitta Sitaram Anjaneyulu	Neelima Hospitals, Hyderabad	Neelima Hospitals, 7-2-1735, Opposite Voltas Limited, Czech Colony, Sanath Nagar, Hyderabad - 500018 Hyderabad ANDHRA PRADESH	09440978535 Csa008@gmail.com
Dr Vivek Arya	NHL Municipal Medical College	Department of Endocrinology, NHL Municipal Medical College, Near Ellisbridge, VS Hospital Campus, Ahmedabad-380006 Ahmadabad GUJARAT	9879537973 vivekarya007@yahoo.com
Dr Pranab Kumar Sahana	Nil Ratan Sarkar Medical College and Hospital	Department of Endocrinology, Nil Ratan Sarkar Medical College and Hospital, 138, AJC Bose Road, Sealdah, Kolkata-700014, West Bengal. Kolkata WEST BENGAL	9231523624 pranabsahana@gmail.com
Dr N Srinivas Rao	Osmania General Hospital	Department of Medicine, Osmania General Hospital, Afzalgunj, Hyderabad-500012 Hyderabad ANDHRA PRADESH	09440235092 drnanyam@yahoo.com
Dr Jyoti Mannari	P.S.Medical College and S.K.Hospital	Ground floor, Room no 108, Department of Medicine,Pramukhswami Medical College,Campus,Karamsad-388325 Anand GUJARAT	9825046138 jyotigm@charutarhealth.com
Dr A L Kakrani	Padmashree Dr. D.Y. Patil Medical College	Department of Medicine, Padmashree Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune-411 018 Pune MAHARASHTRA	09823972424 kakrani@hotmail.com
Dr Sanjay Kumar Bhadada	Post Graduate Institute of Medical Education and Research	Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Sec-12, Chandigarh -160012 Chandigarh CHANDIGARH	9876602448 bhadadask@rediffmail.com
Dr S J Singh	Pragya Multispeciality Hospital and Research Centre	Pragya Multispeciality Hospital & Research Center, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH	09336902975 sjsingh159@gmail.com
Dr Hemant Thacker	Purav Diagnostics, Mumbai	402-B, Sukh Sagar Building, N. S. Patkar Marg, Mumbai 400007 Mumbai MAHARASHTRA	9820073882 drhpt@hotmail.com
Dr Indira Maisnam	R.G.Kar Medical college and Hospital	First floor Room no. 203, Department of Medicine,R.G.Kar Medical College and Hospital, 1, Kshudhiram Bose Sarani, Kolkata,700004 Kolkata WEST BENGAL	9831734752 i.maisnam@gmail.com
Dr Ajith Kumar	Raja Rajeshwari Meidical College and Hospital	Ground floor, Department of Medicine,Raja Rajeshwari Medical College,No202, Kambipura,Mysore Road,Bangalore-560074 Bangalore KARNATAKA	9845243763 ajithvenoor@yahoo.co.in
Dr BLN Prasad	Rajiv Gandhi Institute of Medical Sciences and RIMS Government General Hospital,	First floor, Room no 13, Department of Medicine,Rajiv Gandhi Institute of Medical Sciences and RIMS Government General Hospital,Hudco,Colony,Balaga,Srikakulam-532001 Srikakulam ANDHRA PRADESH	9848211931 amcmedicine@hotmail.com
Dr Debashish Maji	Ramakrishna Seva Pratishthan Vivekanand Institute of Medical Sciences	Ground floor, Room no 19,Department of Medicine,Ramakrishna Seva Pratishthan Viveknand Institute of Medical Sceiences, Kolkata-700026 Kolkata WEST BENGAL	9830109775 d.maji50@gmail.com
Dr CBSreenivasa Rao	Ramdev Rao Hospital	Ground floor, Room no 5, Ramdev Rao Hospital,National Highway No.9, Kukatpally, Hyderabad,Telangana-500072 Hyderabad ANDHRA PRADESH	9848119845 diabetes.hyd@gmail.com
Dr Kamlesh Fatania	Rathi Hospital	Ground floor, room no. 3,Department of Medicine, Near Anupam, Shopping Centre, OPP Mahabaleshwar Society, Jodhpur Cross Road,Sattelite, Ahmedabad-380015 Ahmadabad GUJARAT	9825466788 drkamlesh_fatania@yahoo.co.in
Dr Madhulika Sharma	Santokba Durlabhaji Memorial Hospital cum Research Institute	Fourth floor, room no 418, Department of Medicine,Santokba Durlabhaji Memorial Hospital cum Research Institute,Bhawani Singh Marg,Near Rambagh Circle,Jaipur-302015 Jaipur RAJASTHAN	9829074854 sharmamadhulikadr@gmail.com
Dr VB Singh	Sardar Patel Medical College and PBM Hospital	Ground floor Room no 16,Department of Medicine,S.P. Medical College,PBM Hospital,Bikaner-334001 Bikaner RAJASTHAN	9414136888 vbsingh2@rediffmail.com
Dr AR Pazare	Seth G.S. Medical College and KEM Hospital	First floor, Room no. 26 Department of Medicne,Seth G.S. Medical College and KEM Hospital,Acharya Donge Marg,Parel Mumbai-400012 Mumbai MAHARASHTRA	9820572212 arpazare@rediffmail.com
Dr Kapil Rathi	Seven Hills Healthcare Pvt Ltd	Department of Internal Medicine, Sevenhills Healthcare Pvt. Ltd., Marol Maroshi Road, Andheri East, Mumbai-400059 Mumbai MAHARASHTRA	09967646537 drkapilr@yahoo.co.in
Dr Vijaykumar Warad	Shri B.M.Patil Medical College	Ground floor, Room no 5,Department of Medicine,SHri B.M.Patil Medical College, Solapur Road,Bangaramma Sajjan Campus,Vijayapura,Bijapur-586103 Bijapur KARNATAKA	9448351939 drvijayw@yahoo.co.in
Dr Vishal Gupta	SMS Medical College and attached Hospital	Department of Medicine, SMS Medical College and attached Hospital, Jawaharlal Nehru Marg, Jaipur â€“ 302004 Jaipur RAJASTHAN	8107769802 drvishalguptamd@rediffmail.com
Dr Indira Pattnaik	Sparsh Hospital	Department of Medicine, Sparsh Hospital & Critical Care (P) Ltd, A-407, Saheednagar, Bhubaneswar-751 007 Khordha ORISSA	09437246066 indirapattnaik@yahoo.co.in
Dr R B Sudagar Singh	Sri Ramchandra Medical Centre	First floor, Room no 1 (A1)Department of Endocrinology,Sri Ramchandra Medical Centre, No.1,Ramchandra Nagar,Porur-600116 Chennai TAMIL NADU	9003178899 drsingh7071@gmail.com
Dr S M Imroz	Sri Venkateswara Medical College	Department of General Medicine, Sri Venkateswara Medical College, Alipiri Gate, Tirupati-517507, Andhra Pradesh Chittoor ANDHRA PRADESH	08297573970 imrozmdgm@gmail.com
Dr Biswajit Ghoshdastidar	The Calcutta Medical Research Institute	Department of Internal Medicine, The Calcutta Medical Research Institute, 7/2, Diamond Harbor Road, Kolkata Kolkata WEST BENGAL	09831096830 biswa.dasti@gmail.com
Dr Digambar Naik	Vrundavan Shalby Hospital	Ground floor, patient consultation room,Department of Medicine,Vrundavan Shalby Hospital,NH-17 A,Karaswada,Mapusa,Goa-403507 North Goa GOA	9225989278 naik.digambar@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 61
Name of Committee	Approval Status
Clinical Trial Ethics Committee,Bhatia Hospital,Mumbai	Approved
Ethics Commitee,Rajiv Gandhi Institute of Medical Sciences and RIMS Government Hospital,Srikakulum	Approved
Ethics Committee Diacon Hospital(Diabetes Care and Research Centre),Bangalore	Approved
Ethics Committee for Human Research,Lady Hardinge Medical College,Delhi	Submittted/Under Review
Ethics Committee Government Medical College,Kozhicode	Approved
Ethics Committee, Dr. B. R Ambedkar Medical College, Bangalore	Submittted/Under Review
Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pune	Approved
Ethics Committee, MGM Institute of Health Science, Navi Mumbai	Approved
Ethics Committee, Osmania Medical, Koti, Hyderabad	Submittted/Under Review
Ethics Committee, Sri Venkateswara Institute of Medical Sciences, Tirupati	Submittted/Under Review
Ethics Committee,GMC,Bhavnagar	Approved
Ethics Committee,GMERS Medical College,Gandhinagar	Submittted/Under Review
Ethics Committee,Indira Gandhi Medical College,Shimla	Submittted/Under Review
Ethics Committee,Karpagam Faculty of Medical Sciences and Research	Approved
Ethics Committee,Meditrina Institute of Medical Sciences,Nagpur	Approved
Ethics COmmittee,S.P.Medical College,Bikaner	Approved
Human Research Ethics Committee,Geetanjali Medical College,Udaipur	Approved
Human Research Ethics Committee,GMC and Civil Hospital,Surat	Submittted/Under Review
Institutinal Human Ethics Committee,GMERS Medical College,Gotri	Approved
Institutional Ethics Commitee,Sri Ramchandra Medical University,Chennai	Approved
Institutional Ethics Committe,Santokba Durlabhaji Memorial Hospital,Jaipur	Submittted/Under Review
Institutional Ethics Committee - The Calcutta Medical Research Institute, Kolkata	Approved
Institutional Ethics Committee A.J.Institute of Medical Sciences,Mangalore	Approved
Institutional Ethics Committee for Human Research, Medical College & SSG Hospital, Baroda	Approved
Institutional Ethics Committee of B.J Government Medical College and Sassoon Government Hospital, Pune	Approved
Institutional Ethics Committee, G. Kuppuswamy Naidu Memorial Hospital,Coimbatore	Approved
Institutional Ethics Committee, G.M.E.R.S Medical College and Civil Hospital, Sola, Ahmedabad	Approved
Institutional Ethics Committee, Indian Institute of Diabetes, Thiruvannathapuram	Approved
Institutional Ethics Committee, Indira Gandhi Govt. Medical College & Hospital, Nagpur	Approved
Institutional Ethics Committee, Ispat General Hospital,Rourkela	Approved
Institutional Ethics Committee, JNU Institute for Medical Sciences and Research Center	Approved
Institutional Ethics Committee, King Georges Medical College, Lucknow	Approved
Institutional Ethics Committee, Madras Diabetes Research Foundation, Chennai	Approved
Institutional Ethics Committee, Neelima Hospitals	Approved
Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh	Approved
Institutional Ethics Committee, Smt. NHL Municipal Medical College, Ahmedabad	Submittted/Under Review
Institutional Ethics Committee, Sparsh Hospital & Critical Care P Ltd, Bhubaneswar	Approved
Institutional Ethics Committee,GMC,Amritsar	Approved
Institutional Ethics Committee,GMC,Aurangabad	Approved
Institutional Ethics Committee,H.M.Patel Centre for Medical Care,Karamsad	Approved
Institutional Ethics Committee,ILS Hospital,Kolkata	Approved
Institutional Ethics Committee,KGH,Visakhapatnam	Approved
Institutional Ethics Committee,KIMS,Trivandrum	Approved
Institutional Ethics Committee,Mysore Medical College,Mysore	Approved
Institutional Ethics Committee,R.G.Kar Medical College,Kolkata	Approved
Institutional Ethics Committee,Ramdev Rao Hospital,Hyderabad	Approved
Institutional Ethics Committee,Rathi Hospital	Approved
Institutional Ethics Committee,Seth G.S.Medical College and KEM Hospital,Mumbai	Approved
Institutional Ethics Committee,Shri.B.M.Patil Medical College and Hospital,Bijapur	Approved
Institutional Ethics Committee- N. R.S Medical College, Kolkata	Approved
Institutional Human Ethics Committee, Mahatma Gandhi Medical College and Research Institute, Pondicherry	Submittted/Under Review
InstitutionalEthics Committee,Ramkrishna Mission Seva Patishthan,Vivekanand Institute of Medical Sciences,Kolkata	Approved
KIMS Institutional Ethics Committee, Kempegowda Institute of Medical Sciences, Bangalore	Approved
Lokmanya Tilak Municipal Medical College and General Hospital, Sion, Mumbai	Submittted/Under Review
Marudhar Hospital Ethics Committee	Approved
Medical Ethics Committee Sevenhills Healthcare Pvt.Ltd, Mumbai	Submittted/Under Review
Medilink Ethics Committee, Ahmedabad	Approved
Pragya Ethics Committee, Pragya Multispeciality Hospital & Research Center P Ltd, Varanasi	Approved
Rajarajeshwari Medical College and Hospital,Institutional Ethics Committee,Bangalore	Approved
The Ethics Committee, S.M.S Medical College & Attached Hospitals, Jaipur	Approved
Vrundavan Shalby Ethics Committee,Goa	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: E118\|\|Type 2 diabetes mellitus with unspecified complications,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Hydroxychloroquine tablets	400 mg Orally once daily for 52 weeks
Comparator Agent	NO Comparator	No Comparator

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Patients receiving stable doses of sulfonylurea and at least 1000 mg dose of metformin for at least 3 months. 2. Patients with HbA1c more than 7 % 3.Patients with ideal body weight of more than 60 kg 4. Patients ready to undergo follow-up of 52 weeks 5. Patients ready to give written, signed and dated informed consent to participate in the study

ExclusionCriteria

Details

1. Patients with other than type 2 diabetes (Type 1 diabetes).2.Patients with a history of any retinopathy of any grade including diabetic retinopathy, 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 significant cardiovascular illness limiting participation of patient in a clinical trial.4.Patients receiving/requiring insulin.5.Patients who have used another investigational agent / device or participated in a clinical trial within the last 30 days prior to enrollment.6.Patients with substance abuse will be excluded.7.Pregnant or lactating women.8.Women of childbearing potential not practicing contraception

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Adverse events (clinical and laboratory) and incidence of hypoglycemia	Through-out the duration of the study including week 4, week 8, week 12,week 24, week 36 and week 52

Secondary Outcome

Outcome	TimePoints
Change in HbA1c, FBG,PPG	at week 24 and 52
Change in lipid profile	at week 24 and 52

Target Sample Size

Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0"

Phase of Trial

Phase 4

Date of First Enrollment (India)

15/02/2016

Date of Study Completion (India)

15/12/2020

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

https://wjpr.net/abstract_show/23387

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

The primary purpose of conducting this study is to assess the safety of hydroxychloroquine as an add on therapy to sulfonylurea and metforminwith respect to reported adverse events (clinical and laboratory) and incidence of hypoglycemia in patients with type-2 diabetes. In this study efficacy in terms of change in HbA1c, FBG and PPG and lipid profile will also be assessed.