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

University of Indonesia (UI)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Uveitis

Treatments: Drug: Placebos; Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidum

Study type: Interventional

Funder types: Other

Identifiers

NCT04162314

19-08-1046

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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

Treatment:

Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidum

Control

Placebo Comparator group

Description:

This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days

Treatment:

Drug: Placebos