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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | 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 |
|
| Control | Placebo Comparator | This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-1,3/1,6-D-Glucan Ganoderma lucidum | Drug | Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasiana Lumban Gaol, MD | Contact | 817200249 | +62 | hasiana.lumbangaol@gmail.com |
| Lukman Edwar, SpM(K), Dr | Contact | 811845804 | +62 | lukmanedwar@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Lukman Edwar, SpM(K), Dr | FKUI/RSCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSCM Kirana | Recruiting | Jakarta Pusat | DKI Jakarta | 10320 | Indonesia |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| Placebos | Drug | Placebos |
|