PDF of Trial CTRI Website URL - http://ctri.nic.in
Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 00:23:36 GMT)
CTRI Number CTRI/2011/05/001708 [Registered on: 05/05/2011] - Trial Registered Prospectively Last Modified On 18/06/2011 Post Graduate Thesis No Type of Trial Interventional Type of Study Nutraceutical Study Design Randomized, Parallel Group Trial Public Title of Study A study on the effects of life style and diet in cancer Scientific Title of A study on the effects of lifestyle and diet on 1. Various types of cancers 2. the incidence, response Study to treatment and also on the role of tumor markers and antioxidants in head and neck squamous cell carcinomas and breast cancers Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name FaizalP Trial Coordinator (multi-center study) Designation Lecturer, Dept. of Medical Biochemistry, Affiliation Kannur University, Kerala Address Lecturer, Dept. of Medical Biochemistry, School of Health Sciences, Kannur University, Thalassery Campus, Palayad.P.O, Kerala State Kannur KERALA 670661 India Phone 04902347228 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name FaizalP Query) Designation Lecturer, Dept. of Medical Biochemistry, Affiliation Kannur University, Kerala Address Lecturer, Dept. of Medical Biochemistry, School of Health Sciences, Kannur University, Thalassery Campus, Palayad.P.O, Kerala State Kannur KERALA 670661 India Phone 04902347228 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name FaizalP Designation Lecturer, Dept. of Medical Biochemistry, Affiliation Kannur University, Kerala Address Lecturer, Dept. of Medical Biochemistry, School of Health Sciences, Kannur University, Thalassery Campus, Palayad.P.O, Kerala State Kannur KERALA 670661 India
page 1 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in
Phone 04902347228 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > School of Health Sciences, Kannur University Primary Sponsor Primary Sponsor Details Name FaizalP Lecturer Dept of Medical Biochemistry School of Health Sciences Kannur University Address Lecturer, Dept of Medical Biochemistry, School of Health Sciences, Kannur University, Thalassery Campus, Palayad.P.O, Pin 670 661 Type of Sponsor Research institution Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator FaizalP Lecturer Dept School of Health Department of Medical 04902347228 of Medical Biochemistry Sciences, Kannur Biochemistry, School of School of Health University Health Sciences, [email protected] Sciences Kannur Kannur University University Thalassery Campus, Palayad.P.O Pin 670661, Kerala state Kannur KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Malabar cancer centre Approved 19/02/2011 Yes school of health Approved 29/08/2009 Yes sciences page 1 School of Health Approved 29/08/2009 Yes Sciences, Kannur University continued page2 Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients cancer patients Healthy Human Volunteers normal control Intervention / Type Name Details Comparator Agent Intervention Apple, Grapes, orange, banana, 50 - 100g dosage singly or in pomegranate, garlic in combination for a period of 12 combination, carrot..etc months Inclusion Criteria Inclusion Criteria Age From 25.00 Year(s) Age To 75.00 Year(s) Gender Both Details Age group 25-75,
No serious comorbid illnesses,
only those who are willing to follow up
page 2 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in
Exclusion Criteria Exclusion Criteria Details Age group 1 - 14, comorbid illnesses, unsure of follow up, Method of Generating Random Number Table Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Participant Blinded Primary Outcome Outcome Timepoints Role of Lifestyle and diet in the incidence of 1 year various cancers can be studied Secondary Outcome Outcome Timepoints From the primary outcomes it may be made 1 year possible to show the role of lifestyle and diet on cancer incidence so that the social community may be made more aware of the same Target Sample Size Total Sample Size=200 Sample Size from India=200 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 2/ Phase 3 Date of First 15/06/2011 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details Brief Summary A study of the effects of Lifestyle and Diet on the Incidence, Response to treatment and also on the role of tumor markers and antioxidants in head and neck squamous cell carcinomas and epithelial breast cancers
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