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1 Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar :19:14 GMT) CTRI Nuber Last Modified On 28/11/2015 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/04/ [Registered on: 07/04/2015] - Trial Registered Retrospectively No Observational Registry Single Ar Trial REGISTRY TO DETERMINE DISEASE PROFILE AND TREATMENT PATTERNS IN ADULT NEWLY DIAGNOSED PATIENTS OF HYPOTHYROIDISM A PATIENT REGISTRY TO DETERMINE DISEASE PROFILE AND TREATMENT PARADIGM IN ADULT NEWLY DIAGNOSED PATIENTS OF HYPOTHYROIDISM [THE THYROID REGISTRY] Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (ulti-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) EPID7010 version 1 dated 10-Oct-14 Designation Affiliation Phone Fax Eail Designation Affiliation Phone Fax Eail Designation Affiliation Protocol Nuber Details of Principal Investigator DrBipin Sethi Endocrinologist Care hospital, hyderabad Care Hospital Banjara Hills H No A E Road No.10 Banjara Hills Landark Beside Rainbow Hospital & Opposite Karvy Building & Near Babu Khan Chaber Hyderabad Hyderabad ANDHRA PRADESH India bipinkuarsethi@yahoo.co.uk Details Contact Person (Scientific Query) DrBipin Sethi Endocrinologist Care hospital, hyderabad Care Hospital Banjara Hills H No A E Road No.10 Banjara Hills Landark Beside Rainbow Hospital & Opposite Karvy Building & Near Babu Khan Chaber Hyderabad Hyderabad ANDHRA PRADESH India bipinkuarsethi@yahoo.co.uk Details Contact Person (Public Query) DrBipin Sethi Endocrinologist Consulting endocrinologist Care Hospital Banjara Hills H No A E Road No.10 Banjara Hills Landark Beside Rainbow Hospital & Opposite Karvy Building & Near Babu Khan Chaber Hyderabad Hyderabad ANDHRA PRADESH page 1 / 8

2 Source of Monetary or Material Support Priary Sponsor Details of Secondary Sponsor Countries of Recruitent Sites of Study Phone Fax Eail India Source of Monetary or Material Support > Not applicable as this is a observational Registry Type of Sponsor NIL List of Countries India of Principal Investigator Priary Sponsor Details Abbott India Linited Abbott India Liited 271 Business Park, Ground Floor, Model Industrial Colony, Off Aarey Road, Goregaon (E), Mubai, Maharashtra India Pharaceutical industry-global NIL of Site Site Phone/Fax/Eail Dr Ankur Gehlot ANKUR GEHLOT Pinkcity Super Speciality Hospital,1 A, Laxan Path, Shya Nagar, Dr Ajay Shah Dr AJAY SHAH Shah Hospital,Kabir Marg, Near Collectorate, Bani Park, Dr Aalselvan Dr Aalselvan "joseph clinic;lakshipura, -08" Dr Anantraan DR ANANTRAMAN Nagana Healthcare,7th ain,btm 2nd stage, Dr ANIRBAN MAZUMDAR Dr ANIRBAN MAZUMDAR Diabetes-Obesity, Thyroid & Horone Clinic,26 A Gariahat Road Dr Arvind Aggarwal Dr Arvind Aggarwal Agarwal Heart and Diabetes Clinic,A-2, DDA Market, Shop No. 3, Paschi Vihar, New Delhi dr.a.gahlot77@gail.co ajayshah9@yahoo.co draalselva@gail.c o anantraan1979@ga il.co dranirbanazudar@g ail.co arvindsart@hotail.c o page 2 / 8

3 Dr Ashish Saini Dr Ashish Saini Sparsh Speciality Clinic B-5,Jangpura Extension, India Dr B K Malpani Dr B K Malpani Malpani Nursing Hoe Gangori Bazar, Dr Bipin Sethi Dr Bipin Kuar Sethi Care Hospital H No A E Road No.10 Banjara Hills Landark Beside Rainbow Hospital & Opposite Karvy Building & Near Babu Khan Chaber Hyderabad Hyderabad ANDHRA PRADESH Dr Debalya Sanyal DR DEBMALYA SANYAL Ananda Clinic,36 Block H, New Alipur Road Dr G N Saxena Dr G N Saxena MG Medical College & Hospital,Tilak Nagar, Dr Jagdish Gotur Dr Jagdish Gotur Bhagats Polyclinic, Ganjanwala Lane, Ganjanwala Building II, Second Floor, Borivli (west), Mubai - 92 Mubai drashishsaini@yahoo.c o.in drbalpani@gail.co sethibipin54@gail.co drdebalyasanyal@g ail.co gnsaxena@gail.co drgotur@gail.co Dr Kirti Saudra Dr Kirti Saudra Diabetes Care Clinic, Plot no - 15, V.M. Marg, Opposite Shreeyash Hospital, Sector -19, New Panvel , Mubai Mubai dibocare@hotail.co Dr M K Mukhopadhyay Dr M K Mukhopadhyay Endocrinology clinic, 46 A, Richi Road Dr Mahesh Padsalge Dr Mahesh Padsalge Diabecare-Speciality Diabetes Centre, F2, D1, Devdarsan Apartent, Sector 11, Nerul, Navi Mubai Mubai (Suburban) kukhopadhyay@ya hoo.co.in draheshpadsalge@g ail.co page 3 / 8

4 Dr Medha Oak Dr Medha Oak Oak Hospital, 106, 1st floor, Mahaveer Jyot, Manpada Road, Dobivli (East), Mubai Mubai (Suburban) Dr P Rachandra Dr P RAMCHANDRA Diathy Clinic& Horone Research Institute,MIG2125, 12th Main, 16 cross, Near Dairy Cercle, Yalankar New Town, Dr PURUSOTTAM CHATTERJEE Dr PURUSOTTAM CHATTERJEE Endo Diabetes Clinic,1 D/1, He Dey Lane, Sinthee, Near Rabindra Bharati University, Dr Raghvendra Dr Raghvendra DOT Speciality Clinic 757/6, Garden School Road, Manjunath Nagar, Chikkalsandra Dr Rajiv Gupta Dr Rajiv Gupta E-4/28,KRISHNA NAGAR, Dr Raesh Dargad Dr Raesh Ratanlal Dargad G-1/A Building, Mukund Nagar, Andheri Kurla Road, Andheri (East), Mubai Mubai Dr Ravikant Sarogi Dr Ravikant Sarogi Diabetes and endocrine clinic,30 K, Rakrishna Saadhi Road, Dr S K Shara Dr S K Shara Diabetes, Thyroid and Endocrine Centre Galaxy Diabetes and Thryoid Clinic, A1,Ajer Road, Opp Kaa House,,, Rajasthan oakedha@hotail.co praveenendocrine@g ail.co purush_chatt@reddiff ail.co dotsraghu@gail.co raj8gupta@yahoo.co rohitdargad@hotail.co ravisaraogi@yahoo.co skshara7@gail.co Dr Sanjay Reddy Dr Sanjay Reddy Center For Diabetes & Endocrine Care #410/A, I Stage, III Block, HRBR drsanjaycreddy@yahoo Layout, Landark:.co Near BDA Coplex, page 4 / 8

5 Details of Ethics Coittee Kalyanangar Post, Dr Shailesh Lodha Dr Shailesh Lodha Dear Foundation,759, Mahaveer Nagar 1, Tonk Road, Dr Sujeet Jha Dr Sujeet Jha Max Hospital Max Hospital,2, Press Enclave Road Saket,, Delhi Dr Suitav Barua Dr Suitav Barua Down Town Hospital GS Road, Guwahati, Assa Golaghat ASSAM Dr S M Suresh Dr.S M Suresh Diacare and Research Centre,No. 723/B, 2nd Block, Rajajinagar Dr Deepak Khandelwal DrDeepakKhandelwal Endocrinology Clinic 227 Abica Vihar Paschi Vihar Delhi India saileshlodha@rediffail.co sujeet.jha@axhealthc are.co suit9001@gail.co sureshhospital@gail.c o khandelwalaiis@gai l.co of Coittee Approval Status Date of Approval Is Independent Ethics Coittee? coittee coittee coittee coittee coittee Diabetes Hospital Care hospital ethics coitee Coittee Approved 23/01/2015 No Approved 27/01/2015 No Approved 26/01/2015 No Approved 26/01/2015 No Approved 26/01/2015 No Subittted/Under Review No Date Specified No Approved 02/02/2015 No page 5 / 8

6 Regulatory Clearance Status fro DCGI Health Condition / Probles Studied Coittee Coittee Coittee Coittee Coittee Mahata Gandhi Medical College and Hospital IEC Coittee Coittee Coittee Coittee Coittee Coittee Coittee Coittee Coittee Coittee Max coittee Coittee Coittee Coittee Coittee Coittee Status Not Applicable Health Type Patients Subittted/Under Review No Date Specified No Approved 16/01/2015 No Approved 31/12/2014 No Approved 02/12/2014 No Approved 08/12/2014 No Approved 08/12/2014 No Approved 08/12/2014 No Approved 08/12/2014 No Date No Date Specified Condition Newly diagnosed patients with hypothyroidis page 6 / 8

7 Intervention / Coparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Rando Sequence Method of Concealent Blinding/Masking Type Details Age Fro Age To Gender Details Details Not Applicable Case Record Nubers Not Applicable Year(s) Year(s) Both Inclusion Criteria 1.Newly diagnosed ale or feale hypothyroid patients? 18 years of age 2.Willing to sign patient authorization for prior to any registry procedure Exclusion Criteria 1. Hypothyroid patients already on treatent 2. Patients with hypothyroidis requiring hospital adission for any cause at the tie of enrollent 3. Patients with alignancy or history of alignancy in the last 5 years 4. Pregnant hypothyroid woen at the tie of enrollent Priary Outcoe Outcoe Tiepoints 1) To create a database, to understand patient & disease profile of newly diagnosed patients 2) To evaluate the treatent prescribed to patients and analyze the TSH levels with respect to dose of levothyroxine 3) To deterine coplications and coorbidities associated with hypothyroidis 4) To understand the treatent pattern and follow up ethod for newly diagnosed patient for the period of 12 onths 5) Tolerability of levothyroxine 1) To create a database, to understand patient & disease profile of newly diagnosed patients 2) To evaluate the treatent prescribed to patients and analyze the TSH levels with respect to dose of levothyroxine 3) To deterine coplications and coorbidities associated with hypothyroidis 4) To understand the treatent pattern and follow up ethod for newly diagnosed patient for the period of 12 onths 5) Tolerability of levothyroxine Secondary Outcoe Outcoe Tiepoints Target Saple Size Phase of Trial Date of First Enrollent (India) Date of First Enrollent (Global) Estiated Duration of Trial Recruitent Status of Trial (Global) Recruitent Status of Trial (India) Publication Details Brief Suary NA Total Saple Size=1500 Saple Size fro India=1500 N/A 27/12/2014 No Date Specified Years=1 Months=4 Days=0 Not Applicable Closed to Recruitent of Participants None yet. Study design: NA page 7 / 8

8 Powered by TCPDF ( Patients visiting the investigator for check-up and eeting the selection criteria will be invited to participate in the study. Investigator or a person assigned by the investigator will explain the study and its procedure. Patients willing to participate will provide their consent and sign the patient authorization for (PAF). Only patients willing to sign the patient authorization for will be allowed to participate in the registry. The assessents will be conducted in accordance with physician s standard clinical practice. Patients will be treated by physician as per his routine clinical practice. A 12 onths observational period has been chosen as a length of tie sufficient for collection of data. Follow-up visits for this registry has been recoended keeping in ind the treating physician s usual pattern of follow-up consultations and also unplanned visits by the patients on their own. Physician ay recoend the laboratory investigations and the data will be captured and used for analysis. page 8 / 8