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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 22:37:48 GMT) CTRI Number CTRI/2012/11/003096 [Registered on: 08/11/2012] - Trial Registered Retrospectively Last Modified On 21/02/2019 Post Graduate Thesis No Type of Trial PMS Type of Study Drug Study Design Single Arm Trial Public Title of Study A Risorine study in sputum positive patients after 8 weeks of conventional treatment Scientific Title of TO STUDY EFFECT OF RISORINE THERAPY ON PLASMA RIFAMPICIN LEVELS IN PATIENTS Study WHO REMAIN SPUTUM POSITIVE AT THE END OF 8 WEEKS OF CONVENTIONAL INTENSIVE PHASE THERAPY Secondary IDs if Any Secondary ID Identifier CRSC12005 Version. 01 Dated 02/05/2012 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Deepak Sawhney Trial Coordinator (multi-center study) Designation Medical Advisor, Affiliation Cadila Pharmaceuticals Limited Address Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India. Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India. Ahmadabad GUJARAT 387810 India Phone 9408604065 Fax 02714-221848 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Ashish Akar Query) Designation Manager Affiliation Cadila Pharmaceuticals Limited Address Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India. Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India. Ahmadabad GUJARAT 387810 India Phone 9925669549 Fax 02714-221848 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Bhaumik Mody Designation Manager Affiliation Cadila Pharmaceuticals Limited Address Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India. Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka, Ahmedabad, Gujarat, India. Ahmadabad GUJARAT page 1 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in 387810 India Phone 9825060463 Fax 02714-221848 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > CADILA PHARMACEUTICALS LIMITED Primary Sponsor Primary Sponsor Details Name CADILA PHARMACEUTICALS LIMITED Address Corporate Campus, Sarkhej-Dholka Highway, Village: Bhat, Ahmedabad – 382210, Gujarat, India Type of Sponsor Pharmaceutical industry-Indian 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 Dr Ghanshyam Bagadia Akshar Krupa Hospital Tuberculosis Division, 09824162847 312-316, Aust mangal complex, Sahibaug [email protected] road,Nr Ahmedabad- 380004 Ahmadabad GUJARAT Dr BB MATHUR Dr. B.B MATHURs 3/7, MEDICAL 09414138689 clinic COLLEGE CAMPUS NAGNECHIJI ROAD [email protected] BIKANER - 334001 n Bikaner RAJASTHAN Dr Sanjay Mehndiratta Dr. M. R. Grewal A-22(B), Near Peetal 09829066516 Memorial Hospital Factory, Shastri Nagar, Jaipur- 302016 [email protected] Jaipur RAJASTHAN Dr Rajeev Adkar Dr. Rajeev Adkar s Akarsh Apartment 9822322941 clinic 65/1-B, Nal Stop Karve road, Above Bank of [email protected] India Pune, m Maharashtra PIN: 411004 Pune MAHARASHTRA Dr Shriram Athavale Dr. Shriram Athavales 810, Ganj Peth, Pune, 9822051745 clinic Maharashtra PIN: 411042 shriram.athavale@yaho Pune o.co.in MAHARASHTRA Dr Sudhir Katta Dr. Sudhir Kattas clinic 104, Near Katta 09414075135 Medical Store, Opp. Peetal Factory, Shastri [email protected] Nagar, Jaipur-302016 Jaipur page 2 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in RAJASTHAN Dr Vipul M Patel I.D. Care Clinic 302, Shubham 9909414282 Superspeciality Hospital, Near Sardar [email protected] Patel Statue, o.in Naranpura, Ahmedabad-13 Ahmadabad GUJARAT Dr Shambhu Prasad Kanke General Hospital Block Chowk, Kanke, 9431899207 Singh & Research Centre Pvt. Ranchi-834 006, Ltd Jharkhand, India kankegeneralhospital@ Ranchi gmail.com JHARKHAND Dr Mahindrakar Mahindrakar Chest Dr. Lane, Ghamodia 9890199495 Mrutyunjay Hospital & RICU Factory Compound Nanded, Maharashtra mahindrakarjay@gmail. Pin-431602 com Nanded MAHARASHTRA DrSatish R Mamidwar Mamidwar hospital Behind Tarodekar 9422871211 Market, Vazirabad Nanded, Maharashtra mamidwar@indiatimes. PIN: 431601 com Nanded MAHARASHTRA Dr Vikas Mittal Sanjeevani Hospital New Sanganer Road, 09414457808 Sodala Jaipur - 302019 Jaipur vikasmittal2006@yahoo RAJASTHAN .co.in Dr Prakash Kurmi Shivam Hospital Department of 9925047695 Tuberculosis, c 4, Satyanarayan society, dr_prakashkurmi@yaho near jashodanagar o.co.in cross road, ahmedabad Ahmadabad GUJARAT Dr Gopal Rawal Sparsh Hospital Tuberculosis Division, 079-26464546 100 B, swastik society,Navrangpura, ashraiassociates@yaho Ahmedabad o.com Ahmadabad GUJARAT Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethique Independent Approved 18/05/2012 Yes Ethics Committee (Dr Bagadia), Gandhinagar, Gujarat Ethique Independent Approved 18/05/2012 Yes Ethics Committee (Dr Gopal), Gandhinagar, Gujarat Ethique Independent Approved 12/06/2012 Yes Ethics Committee (Dr Mahindrakar), Gandhinagar, Gujarat Ethique Independent Approved 14/07/2012 Yes page 3 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Ethics Committee (Dr Mathur), Gandhinagar, Gujarat Ethique Independent Approved 18/05/2012 Yes Ethics Committee (Dr Prakash), Gandhinagar, Gujarat Ethique Independent Approved 12/06/2012 Yes Ethics Committee (Dr Rajeev), Gandhinagar, Gujarat Ethique Independent Approved 18/05/2012 Yes Ethics Committee (Dr Sanjay), Gandhinagar, Gujarat Ethique Independent Approved 12/06/2012 Yes Ethics Committee (Dr Satish), Gandhinagar, Gujarat Ethique Independent Approved 12/06/2012 Yes Ethics Committee (Dr Shambhu), Gandhinagar, Gujarat Ethique Independent Approved 12/06/2012 Yes Ethics Committee (Dr Shriram), Gandhinagar, Gujarat Ethique Independent Approved 18/05/2012 Yes Ethics Committee (Dr Shudhir), Gandhinagar, Gujarat Ethique Independent Approved 06/06/2012 Yes Ethics Committee (Dr Vikash), Gandhinagar, Gujarat Ethique Independent Approved 07/07/2012 Yes Ethics Committee (Dr Vipul), Gandhinagar, Gujarat Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Tuberculosis of lung Intervention / Type Name Details Comparator Agent Intervention Risorine Kit Once Daily [one Risorine capsule (Rifampicin 200mg + Isoniazid 300mg + Piperine 10mg) + one tablet of Ethambutol 800mg + Pyrazinamide 2x750mg tablets] orally for 30 days Comparator Agent NA NA Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 60.00 Year(s) page 4 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Gender Both Details •Males/females in the age range of 18-60 years<br/> •Category-I sputum positive pulmonary tuberculosis patients who remain sputum positive at the end of 8 weeks of conventional intensive phase therapy<br/> •Compliance to treatment<br/> •Willing to give informed consent<br/> Exclusion Criteria Exclusion Criteria Details •Sputum negative patients •Pregnant or lactating females or females on oral contraceptives •HIV positive status •Seriously ill and moribund patients •Hypersensitivity to any of the drugs to be administered as part of regimen •Treatment noncompliant patients as per treating physician discretion Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints To evaluate effect of one month’s Risorine 30 days from randomization therapy on plasma rifampicin levels in Category-I sputum positive pulmonary tuberculosis patients who remain sputum positive at the end of 8 weeks of conventional intensive phase therapy (Rifampicin 450mg + Isoniazid 300mg + Ethambutol 800mg + Pyrazinamide 1500 mg, all given once daily). Secondary Outcome Outcome Timepoints NA NA Target Sample Size Total Sample Size=50 Sample Size from India=50 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Post Marketing Surveillance Date of First 10/06/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=3 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Brief Summary Slow responders to standard anti-tubercular therapy are known to have low serum rifampicin levels. These patients remain sputum positive at the end of 8-weeks of intensive therapy. Piperine prevents rifampicin-induced auto-induction & over-expression of P-glycoprotein & thus helps to maintain rifampicin serum levels within therapeutic range. Present study is proposed to measure plasma page 5 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in rifampicin concentrations with Risorine treatment in Category-I sputum positive pulmonary tuberculosis patients who remain sputum-positive at the end of 8 weeks of conventional intensive phase therapy (Rifampicin 450mg + Isoniazid 300mg + Ethambutol 800mg + Pyrazinamide 1500 mg). page 6 / 6 Powered by TCPDF (www.tcpdf.org).
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