The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Change in Quality of Life: SF-36 questionnaire
研究概览
简要总结
The aim of this study is to determine the efficacy and safety of Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum on ulcerative colitis
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years old
- •ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
- •agreed to participate in this study
排除标准
- •ulcerative colitis patients who are treated by corticosteroid, immunosuppressive agents and biologic agents
- •allergic to Ganoderma lucidum
- •could not be randomised and participate in this study by clinical judgement
研究组 & 干预措施
Beta-1,3/1,6-D-Glucan Ganoderma lucidum
This group received capsule contains 180 mg Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum with dose 3x1 capsule a day for 90 days
干预措施: Beta-1,3/1,6-D-Glucan (Drug)
Placebo
This group received empty capsule with dose 3x1 capsule a day for 90 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Quality of Life: SF-36 questionnaire
时间窗: 0 and 90 days
Quality of Life is assessed by Indonesian validated Short Form 36 (SF-36) questionnaire. This questionnaire consist of 36 items/questions that evaluate quality of life in some elements. The elements are change in health (1 item), general health perception (5 items), energy/fatigue (4 items), mental health (5 items), social functioning (2 items), pain (2 items), physical functioning (10 items), role limitations due to emotional problems (3 items) and role limitations due to physical problems (4 items). The score from each question will be summed. Minimum score is 36 and maximum score is 138. Higher score indicates higher quality of life and lower score indicates lower quality of life. Higher score post intervention administration represents a positive outcome
次要结局
- Change of fecal calprotectin level(0 and 90 days)
- Change of C-Reactive Protein (CRP) level(0 and 90 days)
- Change of Erythrocyte Sedimentation Rate (ESR)(0 and 90 days)
- Change of Tumor Necrosis Factor Alpha (TNF-α) level(0 and 90 days)
- Change of Interleukin 6 (IL-6) level(0 and 90 days)
- Change of Mayo score(0 and 90 days)
- Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy(0 and 90 days)
研究者
Marcellus Simadibrata, Prof. PhD., SpPD, KGEH
Professor
Fakultas Kedokteran Universitas Indonesia