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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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JPRN |
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Last refreshed on:
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17 May 2021 |
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Main ID: |
JPRN-UMIN000043344 |
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Date of registration:
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10/04/2021 |
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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 channa striata on tuberculosis in children
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Scientific title:
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The effect of channa striata on tuberculosis outcome in children - effect channa striata on body mass index, Leptin level, albumin level, TNF-s, IFN-gamma in tuberculosis children |
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Date of first enrolment:
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2020/08/01 |
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Target sample size:
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70 |
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Recruitment status: |
Recruiting |
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URL:
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https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049490 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase III
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Countries of recruitment
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Asia(except Japan)
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Contacts
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Name:
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MOH SYAROFIL
ANAM |
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Address:
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Bagian/KSM Ilmu Kesehatan Anak FK Undip/RSUP dr. Kariadi Semarang. Jl. dr Sutomo No.16. Gedung C1L2
50244
Japan |
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Telephone:
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0248414296 |
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Email:
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msanam77@fk.undip.ac.id |
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Affiliation:
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lecturer at diponegoro university faculty of medicine pediatric respirology |
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Name:
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MOH SYAROFIL
ANAM |
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Address:
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Bagian/KSM Ilmu Kesehatan Anak FK Undip/RSUP dr. Kariadi Semarang. Jl. dr Sutomo No.16. Gedung C1L2
Japan |
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Telephone:
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081367428988 |
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Email:
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msanam77@fk.undip.ac.id |
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Affiliation:
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lecturer at diponegoro university faculty of medicine pediatric respirology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: severe tuberculosis form, include extrapulmonary TB, MDR TB
severe malnutrition
severe chronic disease
acute infectious disease on enrollement or admission
HIV positif
Age minimum:
2years-old
Age maximum:
14years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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clinical trial on supplementary drug for tuberculosis in children
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Intervention(s)
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channa striata extract for 2 month
subject 2-5 years dose 2x250 mg
subject 6-14 years dose 2x500 mg
placebo with same form and eticket, with capsul or syrup glukosa base
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Primary Outcome(s)
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outcome of tuberculosis in children after 2 month suplementation of channa striata
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Secondary Outcome(s)
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improvement of albumin level
improvement of leptin level
improvement of cytokine level (TNF-a, IFN-gamma, IGF-beta)
improvement of body mass index
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Source(s) of Monetary Support
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faculty of medicine diponegoro university
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Ethics review
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Status: YES
Approval date: 21/08/2019
Contact:
komisietik@gmail.com
Komisi Etik Penelitian Kesehatan FK Undip
02476928010 (p.7820)
komisietik@gmail.com
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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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01/04/2021 |
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URL:
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