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

Phase 2

• Conditions: Uveitis
• Interventions: Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidum; Drug: Placebos

• Registration Number: NCT04162314
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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.

Study Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-14
• Study Start: 2020-01-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Beta-1,3/1,6-D-Glucan Ganoderma lucidum	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	Placebos	This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

RSCM Kirana; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia