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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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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02191046 |
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Date of registration:
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13/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis
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Scientific title:
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A Randomized- Controlled Study Comparing the Effect of Squeezable Bottle Nasal Irrigation Device With Syringe in Children With Sinusitis |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02191046 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Araya Satdhabudha, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Thammasat University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. age 3-15 years
2. diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory
infection symptoms > or = 10 days 2.2. severe upper respiratory infection symptom with
greenish discharge per nose or periorbital swelling 2.3 double sickening of upper
respiratory infection symptoms
Exclusion Criteria:
1. patient who has history of penicillin allergy
2. patient who has complication of sinusitis
3. patient with a history of nasal anatomical defects
4. patient who has immune deficiency or primary ciliary dyskinesia
Age minimum:
3 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sinusitis
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Intervention(s)
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Device: syringe 20 ml
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Device: squeezable bottle
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Primary Outcome(s)
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the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children
[Time Frame: compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment]
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Secondary Outcome(s)
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the Contamination in Nasal Irrigation Devices
[Time Frame: at second week after treatment]
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Secondary ID(s)
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45/2555
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?? 45/2555
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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