Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Non-infectious and Idiopathic Uveitis
NCT ID: NCT04162314
Last Updated: 2021-02-03
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
20 participants
INTERVENTIONAL
2020-01-21
2021-12-31
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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Experimental
This group received combination of mycelium extract of Ganoderma lucidum capsule containing 180 mg Beta-1,3/1,6-D-Glucan with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days
Beta-1,3/1,6-D-Glucan Ganoderma lucidum
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Control
This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days
Placebos
Placebos
Interventions
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Beta-1,3/1,6-D-Glucan Ganoderma lucidum
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Placebos
Placebos
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Indicated to receive oral steroid and have signs of anterior segment inflammation.
3. Anterior chamber inflammation \>= +2 according to SUN criteria.
4. Age between 18 and 65 years old, good general condition, consented to be involved in the research, and are willing to come regularly according to follow up schedule.
Exclusion Criteria
2. Received antibiotics one week before the start of the trial.
3. Contraindicated to oral steroid.
4. Other primary ocular disorder, such as glaucoma, anterior segment dysgenesis, or others.
5. Pregnant and nursing women.
6. Patients with history of hypersensitivity/ allergy to Ganoderma species or other fungi.
18 Years
65 Years
ALL
Yes
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Responsible Party
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Hasianalumban
Ophthalmology resident
Principal Investigators
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Lukman Edwar, SpM(K), Dr
Role: PRINCIPAL_INVESTIGATOR
FKUI/RSCM
Locations
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RSCM Kirana
Jakarta Pusat, DKI Jakarta, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-08-1046
Identifier Type: -
Identifier Source: org_study_id
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