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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
204
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Placebo capsule three times daily for 90 days
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta, Jakarta Pusat, Indonesia
Change in Quality of Life: SF-36 questionnaire
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
Time frame: 0 and 90 days
Change of C-Reactive Protein (CRP) level
Level of CRP is obtained from laboratory test.
Time frame: 0 and 90 days
Change of Erythrocyte Sedimentation Rate (ESR)
ESR is obtained from laboratory test.
Time frame: 0 and 90 days
Change of Tumor Necrosis Factor Alpha (TNF-α) level
Level of TNF-α is obtained from laboratory test
Time frame: 0 and 90 days
Change of Interleukin 6 (IL-6) level
Level of IL-6 is obtained from laboratory test
Time frame: 0 and 90 days
Change of fecal calprotectin level
Level of fecal calprotectin is obtained from stool examination
Time frame: 0 and 90 days
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Change of Mayo score
Mayo score is assessed from colonoscopy. 0 = normal 1 = mild (erythema, decreased vascular pattern, mild friability) 2 = moderate (marked erythema, absent vascular pattern, friability, erosions) 3 = severe (spontaneous bleeding, ulceration)
Time frame: 0 and 90 days
Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy
Colon biopsy is obtained from colonoscopy and histopathology examination
Time frame: 0 and 90 days