Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Non-infectious and Idiopathic Uveitis

Study Overview
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Brief Summary
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To investigate the effect of Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum as an adjuvant to methylprednisolone for non-infectious and idiopathic uveitis

Detailed Description
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Patients with non-infectious and idiopathic uveitis will receive standard treatment with methylprednisolone, but will be randomized to receive either Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum or placebo. Follow up will be performed on week-2, week-4, week-6, month-2, and month-3. Outcomes measured are anterior chamber cells, visual acuity, and serum TNF-alpha levels.

Official Title
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The Role of β-1,3/1,6-D-Glucan From Extract of Indonesian Ganoderma Lucidum Mycelium as a Combination Therapy With Methylprednisolone for Treatment of Non-infectious and Idiopathic Uveitis: A Double-blind Randomized Pilot Study

Conditions
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Uveitis

Intervention / Treatment
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* Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidum
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with non-infectious and idiopathic uveitis. Indicated to receive oral steroid and have signs of anterior segment inflammation. Anterior chamber inflammation >= +2 according to SUN criteria. 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: Received systemic steroid and/other immunosuppressive drugs two weeks before the start of the trial. Received antibiotics one week before the start of the trial. Contraindicated to oral steroid. Other primary ocular disorder, such as glaucoma, anterior segment dysgenesis, or others. Pregnant and nursing women. Patients with history of hypersensitivity/ allergy to Ganoderma species or other fungi.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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 | Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidum<br>* Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days<br>* Other names: PsP;|
| Placebo Comparator: Control<br>This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days | Drug: Placebos<br>* Placebos<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anterior chamber inflammatory cells grading | Change in anterior chamber inflammatory cells grading according to SUN nomenclature (0, 0.5+, 1+, 2+, 3+, 4+). 0 is minimum value (better outcome) and +4 is maximum value (worse outcome). | Baseline, week-2, week-4, week-6, month-2, month-3 | 
| Change of serum TNF-alpha level | Change of serum TNF-alpha level | Baseline, week-6, month-3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-infectious uveitis, idiopathic uveitis