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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2017/03/008048 |
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Date of registration:
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08-03-2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A test is done with sweta gunja (Abrus precatorius) application in nasal polyp to assess the before and after outcome.
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Scientific title:
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A pre and post test clinical study to assess the treatment outcomes of Sweta- Gunja Lepa (Abrus Precatorius Application) in Ethmoidal Nasal Polyp |
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Date of first enrolment:
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03-04-2017 |
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Target sample size:
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30 |
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Recruitment status: |
Other (Terminated) |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17002 |
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Study type:
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Interventional |
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Study design:
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Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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ksivabalaji
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Address:
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Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala
690525
Kollam, KERALA
India |
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Telephone:
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7559027947 |
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Email:
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balajisiva85k@gmail.com |
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Affiliation:
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amrita school of ayurveda |
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Name:
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ksivabalaji
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Address:
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Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala Amrita school Of Ayurveda , vallikavu, Clappana Post, kollam , kerala
690525
Kollam, KERALA
India |
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Telephone:
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7559027947 |
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Email:
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balajisiva85k@gmail.com |
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Affiliation:
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amrita school of ayurveda |
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Key inclusion & exclusion criteria
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Inclusion criteria: Bilateral polpoidal mass in nose with headache and nasal blockage after confirming the diagnosis by CT PNS (Computed Tomography â?? Para nasal sinuses).
Exclusion criteria: •Patients with Antro chonal polyp, malignant conditions of nose.
•Any other nasal pathologies leading to nasal blockage.
•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)
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- patient with ethmodial nasal polyp
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Intervention(s)
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Intervention1: Abrus Precatorius application in ethmodial nasal polyp: endoscopy grading will be calculated
Intervention2: nil: nil
Intervention3: A pre and post test clinical study to assess the treatment outcomes of Sweta- Gunja Lepa (Abrus Precatorius Application) in Ethmoidal Nasal Polyp: dose - 5 gms
frequency duration - weekly once for 2 months
route of administration- nasal cavity
Control Intervention1: trail not applicable: Trail not applicable
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Primary Outcome(s)
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reduction in the size of the mass in nasal polyp by endoscopy gradingTimepoint: estimated time point is after 2 years ie 2010
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Secondary Outcome(s)
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reduction in the size of the mass in nasal polyp by endoscopy gradingTimepoint: FOLLOW UP FOR 24 MONTHS
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Source(s) of Monetary Support
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AMRITA SCHOOL OF AYURVEDA
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Ethics review
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Status: Approved
Approval date: 05/12/2016
Contact:
amrita institute of medical sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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22/11/2022 |
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URL:
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