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
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in anterior chamber inflammatory cells grading
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days
干预措施: Placebos (Drug)
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
干预措施: Beta-1,3/1,6-D-Glucan Ganoderma lucidum (Drug)
结局指标
主要结局
Change in anterior chamber inflammatory cells grading
时间窗: 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
时间窗: Baseline, week-6, month-3
Change of serum TNF-alpha level
次要结局
未报告次要终点
研究者
Hasianalumban
Ophthalmology resident
Fakultas Kedokteran Universitas Indonesia