Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis
NCT ID: NCT04029649
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
204 participants
INTERVENTIONAL
2019-08-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Beta-1,3/1,6-D-Glucan Ganoderma lucidum
This group received capsule contains 180 mg Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum with dose 3x1 capsule a day for 90 days
Beta-1,3/1,6-D-Glucan
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Placebo
This group received empty capsule with dose 3x1 capsule a day for 90 days
Placebo
Placebo capsule three times daily for 90 days
Interventions
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Beta-1,3/1,6-D-Glucan
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Placebo
Placebo capsule three times daily for 90 days
Eligibility Criteria
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Inclusion Criteria
* ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
* agreed to participate in this study
Exclusion Criteria
* allergic to Ganoderma lucidum
* could not be randomised and participate in this study by clinical judgement
18 Years
ALL
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Marcellus Simadibrata, Prof. PhD., SpPD, KGEH
Professor
Principal Investigators
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Marcellus Simadibrata
Role: PRINCIPAL_INVESTIGATOR
Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
Locations
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RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta, Jakarta Pusat, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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19-01-0083
Identifier Type: -
Identifier Source: org_study_id
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