Uveitis
Conditions
Keywords
non-infectious uveitis, idiopathic uveitis
Brief summary
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
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.
Interventions
DRUGBeta-1,3/1,6-D-Glucan Ganoderma lucidum
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
DRUGPlacebos
Placebos
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients with non-infectious and idiopathic uveitis. 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
1. Received systemic steroid and/other immunosuppressive drugs two weeks before the start of the trial. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anterior chamber inflammatory cells grading | Baseline, week-2, week-4, week-6, month-2, month-3 | 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). |
| Change of serum TNF-alpha level | Baseline, week-6, month-3 | Change of serum TNF-alpha level |
Countries
Indonesia
Contacts
Primary ContactHasiana Lumban Gaol, MD
Backup ContactLukman Edwar, SpM(K), Dr
Outcome results
None listed