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CTRI Trial Data

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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 14:53:09 GMT) CTRI Number CTRI/2017/03/008048 [Registered on: 08/03/2017] - Trial Registered Prospectively Last Modified On 22/11/2017 Post Graduate Thesis No Type of Trial Interventional Type of Study Ayurveda Study Design Single Arm Trial Public Title of Study A test is done with sweta gunja (Abrus precatorius) application in nasal polyp to assess the before and after outcome. Scientific Title of A pre and post test clinical study to assess the treatment outcomes of Sweta- Gunja Lepa (Abrus Study Precatorius Application) in Ethmoidal Nasal Polyp Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name ksivabalaji Trial Coordinator (multi-center study) Designation assistant Professor Affiliation amrita school of ayurveda Address Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Kollam KERALA 690525 India Phone 7559027947 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name ksivabalaji Query) Designation assistant Professor Affiliation amrita school of ayurveda Address Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Kollam KERALA 690525 India Phone 7559027947 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name ksivabalaji Designation assistant Professor Affiliation amrita school of ayurveda Address Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Kollam KERALA page 1 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in 690525 India Phone 7559027947 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > AMRITA SCHOOL OF AYURVEDA Primary Sponsor Primary Sponsor Details Name amrita school Of ayurveda Address Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Type of Sponsor Other [ayurveda college & hospital] 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 ksivabalaji Amrita Ayurveda Department of 7559027947 hospital Shalkaya tantra, Room 7559027947 no 2, Amrita Ayurveda [email protected] hospital m Kollam KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? amrita institute of Approved 05/12/2016 No medical sciences Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients patient with ethmodial nasal polyp Intervention / Type Name Details Comparator Agent Intervention A pre and post test clinical study dose - 5 gms frequency duration to assess the treatment - weekly once for 2 months outcomes of Sweta- Gunja Lepa route of administration- nasal (Abrus Precatorius Application) cavity in Ethmoidal Nasal Polyp Comparator Agent trail not applicable Trail not applicable Inclusion Criteria Inclusion Criteria Age From 25.00 Year(s) Age To 50.00 Year(s) Gender Both Details Bilateral polpoidal mass in nose with headache and nasal blockage after confirming the diagnosis by CT PNS (Computed Tomography – Para nasal sinuses). Exclusion Criteria Exclusion Criteria Details •Patients with Antro chonal polyp, malignant conditions of nose. •Any other nasal pathologies leading to nasal blockage. page 2 / 3 PDF of Trial CTRI Website URL - http://ctri.nic.in •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study •Subject unlikely to comply with protocol (e.g. non-compliance, inability to return for follow-up visits, and likelihood of not completing the study) Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints reduction in the size of the mass in nasal polyp estimated time point is after 2 years ie 2010 by endoscopy grading Secondary Outcome Outcome Timepoints reduction in the size of the mass in nasal polyp FOLLOW UP FOR 24 MONTHS by endoscopy grading Target Sample Size Total Sample Size=30 Sample Size from India=30 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 N/A Date of First 03/04/2017 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=20 Trial Months=2 Days=15 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Other (Terminated) Trial (India) Publication Details Brief Summary A pre and post test clinical study to assess the treatment outcomes of Sweta- Gunja Lepa (Abrus Precatorius Application) in Ethmoidal Nasal Polyp is the clinical study The Treatment period is 2 months, weekly onces sweta gunja lepa will be applied and follow up will be done 4 monthly once for 24 months. Assessment will be done basis of reduction in the size of the mass by nasal endoscopy. Results will be statistically analyzed page 3 / 3 Powered by TCPDF (www.tcpdf.org).
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