Clinical Trial Details (PDF Generation Date :- Tue, 19 Mar 2019 18:08:08 GMT) CTRI Number CTRI/2009/091/000355 [Registered on: 22/01/2010] - Last Modified On Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Single Arm Trial A clinical trial to study the effects of cerebroprotien hydrolysate in patients with all type of dementia. An evaluation of efficacy and safety of cerebroprotein hydrolysate in the management of subjects with dementia in an open labeled, prospective, phase-iii clinical trial. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NEX/LUP/CT-III-505/04/2008 Protocol Number Details of Principal Investigator Dr.Vidyadhar Bhede Phone 91-9324528043 Fax Vithai Hospital, Doctor Lane Nanded Nanded 431601 drsvidyadhar@yahoo.co.in Details Contact Person (Scientific Query) Dr.Amit Bhatt CEO Phone 91-22-27714204 Fax Ext. 108 Anuj, Plot No. 45, Ist Floor, Sector-13, Nerul (E) Mumbai 400706 hbo@nexuscro.com Details Contact Person (Public Query) Dr.Alok Chaturvedi Phone 91-22-66402021 Fax Laxmi Towers, B wing, 4th floor, Bandra Kurla Complex, Bandra East, Mumbai 400051 alokchaturvedi@lupinpharma.com page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Source of Monetary or Material Support > Lupin Limited Laxmi Towers, B wing, 4th floor, Bandra Kurla Complex, Bandra East, Mumbai-400 051,. Telephone: 91-22-66402021 Type of Sponsor List of Countries of Principal Investigator Dr. Vilas Bhailume DR S K GUPTA Dr. Arshad Hussain Primary Sponsor Details Lupin Limited Laxmi Towers, B wing, 4th floor, Bandra Kurla Complex, Bandra East, Mumbai-400 051,. Telephone: 91-22-66402021 of Site Site Phone/Fax/ Aroma Terrace, Flat No.1 GOVT,HOSPITAL JAMMU Govt. Psychriatric Disease Hospital Aroma Terrace, Flat No.1,Ground Floor, Karvenagar Bus Stop, Warje-411052 Pune DEPPTT,OF MEDICINE,HEAD :NEUROLOGY SECTION-nil Jammu,- Srinagar Dr. Sandeep Sehgal Hope Hospital W.K. Road,- Meerut UTTAR PRADESH Dr. Vishal Sonawane Dr. Parvaiz Ahmed Shah Nityanand Rehab Centre Dr. Vidyadhar V. Bhede Vithai Hospital Patang Plaza,behind Bharati Vidyapeeth- Pune SHMS Hospital,-190014 Srinagar Doctor Lane,-431601 Nanded 91-9422003360 09419184600 nil skgupta@gmail.com 91-9419041813 arshadtina@yahoo.co.i n 91-9837090908 ssehgal1970@hotmail.c om 91-9822997527 91-194-2438955 parvaizshah11@rediffm ail.com 91-9324528043 drsvidyadhar@yahoo.c o.in of Committee Approval Status Date of Approval Is Committee? Research ()(DR ARSHID HUSSAIN) page 2 / 5
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Research ()(DR PARVAIZ SHAH) Research ()(DR S K GUPTA) Research ()(DR SANDEEP SEHGAL) Research ()(DR VIDYADHAR V.BHEDE) Research ()(DR VILAS BHAILUME) Research ()(DR VISHAL SONAWANE) Status Approved/Obtained Health Type Date No Date Specified Condition All types of dementia Type Details Intervention Cerebroprotein Hydrolysate 60-180 mg per day for infusion, Duration- once a day for 20 days Comparator Agent Age From Age To Gender Details Inclusion Criteria 1. Subjects with all types of dementia. 2. Subjects of either sex of aged between 40 to 85 years. 3. Pre menopausal women with appropriate contraception. 4. Subjects with Mini Mental State Examination score 15 to 25. 5. Subjects with Global Deterioration Scale rating of 3 to 5. 6. Subjects with Hamilton Depression Scale rating of 15. 7. Subjects with normal vitamin-b12 and Folate level. 8. Subjects with normal T3, T4, and TSH hormones. 9. Subjects with normal LFT and RFT. 10. All subjects with vision and hearing sufficient for compliance with testing procedure. 11. Willing to give written informed consent. Exclusion Criteria page 3 / 5
Method of Generating Random Sequence Method of Concealment Blinding/Masking Details 1. Subjects with evidence of other psychiatric or neurological disorders. 2. Subjects with clinically significant or active renal, hepatic, endocrine, or cardiovascular diseases. 3. Subjects with severe lung disease. 4. Subjects with major depressions. 5. Subjects with cardiac dysfunction/surgery. 6. Subjects with uncontrolled hypertension 7. Subjects with haematological or oncological disorders. 8. Subjects with Vitamin B12 or folate deficiency. 9. Subjects with a known history of hypersensitivity from any one of the said medication 10. Subject those who just experienced cardiac surgery or applied expansion cardio-cerebrovascular treatment and Neurotrophic drugs and nootrophic drugs user (can be taken into group two weeks after drug discontinuation) 11. The patient has a history of stroke or after examination some stroke evidence can be found, or there are signs of stroke in Quiet Zone of MRI cerebral cortex. 12. Subjects have used the investigational drug within 4 months before entering the trial. 13. Subjects using psychotropic drugs, drug influencing cerebral blood flow, or stimulants. 14. Pregnant women or lactating woman. 15. Subjects with history of alcohol and drug of abuse. Primary Outcome Outcome Timepoints Activities of daily living rated by physician baseline, 10th day, 20th day Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Incidence of all adverse events? Common?Solicited local and systemic reactions? Unsolicited AEs (including abnormal laboratory value)? SAEs during the study period Total Sample Size=100 Sample Size from = No Date Specified 10/04/2009 Years= Months=3 Days=10 Completed 20 days The study was conducted after obtaining written informed consent from the subjects. The subjects were undergone medical screening during pre-study evaluation (E1). Screening process included complete clinical evaluation (Subject medical history, physical examination, record of height, weight and vital signs), and laboratory tests {Routine Haematology, Biochemistry (electrolyte, calcium, blood sugar), urine analysis and microscopy, Liver function tests (SGOT, SGPT, Serum Bilirubin), Renal Function Tests (Serum Creatinine, and Serum Uric Acid), Thyroid function test (T3, T4, TSH), Vitamin B12 and Folate test, Drug of abuse(5 drug panel) Midstream urine test on possibility of delirium, ECG, Chest X-ray and MRI}. Blood sample were collected for laboratory evaluations during screening. Female volunteers of child bearing capability were subjected to a urine pregnancy test. In all cases; Structural imaging (MRI) was used in the assessment of people with suspected page 4 / 5
Powered by TCPDF (www.tcpdf.org) dementia and to exclude other cerebral pathologies and to help establish the subtype diagnosis, Hachinski scale (see annexure-vi) [13] was used to differentiate the subject for AD and VD before diagnosis. Once the subject was diagnosed with mild to moderately severe dementia according to Diagnostic and Statistical Manual of Mental Disorders-(DSM-) IV criteria and ICD-10 criteria had been made prior to enrollment, upon the enrollment of a subject the quality of life, and efficacy assessment were done day 1, at day 10 and after the completion of protocol treatment. Lyophilized Cerebroprotein Hydrolysate (for injection) therapy was administer through intravenous infusion for 20 days OD. ADR was monitored for solicited and unsolicited drug reactions on daily basis. Upon the completion of therapy again all the laboratory tests {Routine Haematology, Biochemistry, Liver function tests, Renal Function Tests, Chest X-ray, ECG} were done for the safety analysis. page 5 / 5