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1 Clinical Trial Details (PDF Generation Date :- Mon, 24 Dec :22:00 GMT) CTRI Number Last Modified On 03/07/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/02/ [Registered on: 02/02/2017] - Trial Registered Prospectively No PMS Drug Single Arm Trial An Open Label, Multicentre, Phase IV Study to Evaluate the Safety and Treatment Effects of Tebokan forte (Ginkgo Biloba EGb 761 ) One Tablet of 120 mg Twice Daily in Adult Patients with Dementia An Open Label, Multicentre, Phase IV Study to Evaluate the Safety and Treatment Effects of Tebokan forte (Ginkgo Biloba EGb 761 ) One Tablet of 120 mg Twice Daily in Adult Patients with Dementia Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Designation Affiliation Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr R Valavan Head Scientific Affairs Phone Fax Designation Affiliation Dr. Willmar Schwabe India Pvt Ltd A-36, Sector - 60, Phase-III, Noida A-36, Sector - 60, Phase-III, Noida Gautam Buddha Nagar UTTAR PRADESH India Dr.valavan@schwabeindia.com Details Contact Person (Public Query) Ravi Kumar Manchanda Manager Regulatory Affairs Dr. Willmar Schwabe India Pvt Ltd A-36, Sector - 60, Phase-III, Noida A-36, Sector - 60, Phase-III, Noida Gautam Buddha Nagar UTTAR PRADESH India page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > Dr Willmar Schwabe India Pvt Ltd A 36 Phase 3 Sector 60 Noida District Gautam Budh Nagar Uttar Pradesh India Type of Sponsor List of Countries India of Principal Investigator Dr Yogesh Kumar Gupta Dr PN Renjan Dr Pradip Kumar Saha Dr Jaykumar Gunjkar Primary Sponsor Details Dr Willmar Schwabe India Pvt Ltd A-36 Phase III Sector 60 Noida Pharmaceutical industry-global of Site Site Phone/Fax/ Ganadhipati Purushottam Shekhawati Hospital & Research Centre Indraprastha Apollo Hospitals Institue of Postgraduate Medical Education and Research Lifepoint Multispecialty Hospital, Pune A/2, opposite (Time Square), Central Spine, Vidhyadhar Nagar,Jaipur , Rajasthan, India Jaipur RAJASTHAN Department of Neurology Indraprastha Apollo Hospitals Sarita Vihar Delhi Mathura Road New Delhi DELHI Institute of Post Graduate Medical Education and Research 244, AJC Bose Road Kolkata , West Bengal Kolkata WEST BENGAL Lifepoint Multispecialty Hospital, 145/1, Mumbai Bangalore Highway, Near Wakad, Pune Pune MAHARASHTRA Dr Ajit Kumar Roy Manipal Hospital Department of Neurology, #98, HAL Airport Road, Bangalore , Karnataka, India. Bangalore KARNATAKA Dr Puneet Agarwal Max Super Specialty Hospital Max Super Specialty Hospital West Block info@shekhawatihospit al.org pnrenjan@rediffmail.co m info@gmail.com gunjkar.jaykumar118@ gmail.com ajith.kumar@manipalho spitals.com page 2 / 7

3 Dr Vemireddy Radhika Reddy Dr Debashish Chowdhury Dr S Vijaya Bhaskara Gupta Dr Vaishal Vora Dr Subarna Telang Dr Sangeetha Ravat Dr Anoop Vincent Old Govt. General Hospital (associated by Govt. Siddhartha Medical College) Postgraduate Medical Education & Research (GIPMER Rajiv Gandhi Institute of Medical Sciences & RIMS Govt General Hospital Ratandeep Multispecialty Hospital Ruby Hall Clinic Grant Medical Foundation Seth GS Medical College KEM Hospital Sree Narayana Institute of Medical Sciences Press Enclave Road Saket New Delhi New Delhi DELHI Department Of Psychiatry, Hanumanpet, Two Town, Vijayawada , Andhra Pradesh, India Krishna ANDHRA PRADESH Department of Neurology GB Pant Institute of Postgraduate Medical Education and Research Jawaharlal Nehru Marg New Delhi New Delhi DELHI Rajiv Gandhi Institute of Medical Sciences (RIMS) Govt General Hospital Research Wing 2nd Floor Beside FM Ward Srikakulam Srikakulam ANDHRA PRADESH 2nd Floor Nakshatra Complex Above HDFC Bank Maninagar Crossroads Maninagar Ahmadabad GUJARAT puneet.agarwal@maxh ealthcare.com rrvemireddy@yahoo.co m debashishchowdhury@ hotmail.com rimsrearch@gmail.com vnvora@gmail.com Clinical Research Department Cancer Building 1st Floor Room suparnashri@yahoo.co No 107 Ruby Hall Clinic m 40 Sassoon Road Pune Maharashtra Pune MAHARASHTRA Ward No 10 2nd Floor Old Building Department of Neurology Seth GSMC & KEM Hospital Parel Mumbai Mumbai MAHARASHTRA 2nd Floor Dept Of Psychiatry Challaka N-Kuthiya Thodu Ernakulam Ernakulam KERALA ravatsh@yahoo.com anoop.vincent@yahoo. co.in Details of Ethics of Committee Approval Status Date of Approval Is Independent Ethics page 3 / 7

4 Committee Regulatory Clearance Status from DCGI Ethics Committee of Manipal Hospital, Bangalore Ethics Committee of Siddhartha Medical College and Govt Hospital Vijayawada Approved 16/06/2017 No Approved 06/07/2017 No Ganadhipati Purushottam Shekhawati Hospital & Research Centre Ethics Committee Approved 07/11/2017 No Committee - Maulana Azad Medical College, 3rd Floor, Room No 306A, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi Committee Institute of Postgraduate Medical Education and Research Committee Rajiv Gandhi Institute of Medical Science and RIMS Government General Hospital Approved 21/03/2017 Yes Approved 27/11/2017 No Approved 11/10/2017 No Committee, Seth GS Medical College KEM Hospital, Parel, Mumbai Approved 24/07/2017 Yes Institutional Indraprasth aapollohospitalssarita ViharDelhiMathuraRoad NewDelhi Approved 16/11/2016 No LPR Ethics Committee, Lifepoint Multispecialty Hospital Max Healthcare Ethics Committee, Max Super Specialty Hospital, 1 Press Enclave Road, Saket, New Delhi RatandeepMultispecialt yhospital RubyHallClinicGrantMe dicalfoundation Approved 01/09/2017 No No Date Specified No Approved 01/10/2016 No Approved 10/09/2016 No SreeNarayanaInstituteo Approved 12/12/2016 No fmedicalscienceschalla ka Status Date Approved/Obtained 11/08/2016 Committee? page 4 / 7

5 Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Health Type Patients Condition Patients diagnosed with dementia including Alzheimers disease vascular dementia or mixed dementia Type Details Intervention Tebokan forte (Ginkgo biloba leaves extract (EGb 761 ) Comparator Agent Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria Dose 120 mg film coated tab Frequency Twice Daily Route of Administration Oral Total duration of therapy 18 weeks 1 Subjects with at least 50 years of age 2 Subjects diagnosed with dementia specifically Major Neurocognitive Disorder due to Alzheimers disease Major Vascular Neurocognitive Disorder or mixed form of both in accordance with DSM 5 criteria cf section MMSE between 12 and 24 inclusive 12 to 18 moderate dementia and 19 to 24 mild dementia 4 Presence of a caregiver 5 Subject LAR ready to give written consent to participate in the trial and ready to follow all study related procedures 6 Post menopausal female subjects or non menopausal female subjects with negative serum pregnancy test and willing to use a reliable means of contraception other than or in addition to hormonal contraceptives eg double barrier method diaphragm plus spermicide condom plus spermicide, etc surgical sterilization or abstinence for the duration of the study. 7 Subjects not participating in any other clinical trial since last 6 months Exclusion Criteria Details Exclusion Criteria Subjects diagnosed with dementia except AD VD or mixed dementia Subjects currently undergoing treatment for depression Subjects with major depression or other psychiatric disorder hospitalized for depression within one year prior to baseline visit Use of Ginkgo biloba within 8 weeks prior to baseline visit Use of cholinesterase inhibitor within 6 months of baseline visit History of any bleeding abnormalities other than in the context of anti platelet or anti coagulant drugs Any other type of neurological disorder as per investigator s discretion Active malignant disease HIV or serious infection as per investigators discretion Subjects currently on cognitive enhancers cholinergic anti cholinergic or haemorheologically active drugs Severe or insufficiently controlled cardiovascular renal or hepatic disorder diabetes anaemia or thyroid dysfunction as per investigator s discretion Method of Generating Random Sequence Method of Concealment page 5 / 7

6 Blinding/Masking Primary Outcome Outcome Timepoints Number of presumed adverse drug reactions and percentage of subjects with presumed adverse drug reactions between baseline and week 18 Number of adverse events and percentage of subjects with adverse events between baseline and week 18 Number of serious adverse events and percentage of subjects with serious adverse events between Changes in the vital signs physical and laboratory examination between baseline and week 18 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 4 Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary Change from baseline to week 18 in a picture learning test representing attention and memory CERAD constructional praxis and recall of constructional praxis Change from baseline to week 18 in the Trail Making Test A and B representing speed and executive functioning Number and percentage of patients with improvement in cognitive functioning from baseline to week 18 for Trail Making Test and CERAD constructional praxis and recall of constructional praxis either or both Change from baseline to week 18 in the BEHAVE AD Change in CGI scale from baseline to week 18 Number and percentage of subjects improving or recovering from vertigo and or tinnitus from baseline through week 18 via 11 Point Box Scales for vertigo and tinnitus Total Sample Size=150 Sample Size from India=150 20/03/2017 No Date Specified Years=1 Months=7 Days=0 Closed to Recruitment of Participants This is an open label, multicentre, phase IV study to assess the safety and therapeutic effects of Tebokan forte (Ginkgo biloba dry extract EGb 761 ) one tablet of 120 mg administered twice daily in subjects diagnosed with dementia. In this study subjects with at least 50 years of age and diagnosed with dementia in page 6 / 7

7 Powered by TCPDF ( PDF of Trial accordance with DSM-5 criteria will be enrolled. During the study a care giver should always accompany with the subject. page 7 / 7