Ulcerative Colitis
Conditions
Keywords
Beta-1,3/1,6-D-Glucan, Ganoderma lucidum, Ulcerative colitis
Brief summary
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
Interventions
DRUGPlacebo
Placebo capsule three times daily for 90 days
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Sponsors
Fakultas Kedokteran Universitas Indonesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥18 years old * ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg * agreed to participate in this study
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life: SF-36 questionnaire | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of C-Reactive Protein (CRP) level | 0 and 90 days | Level of CRP is obtained from laboratory test. |
| Change of Erythrocyte Sedimentation Rate (ESR) | 0 and 90 days | ESR is obtained from laboratory test. |
| Change of Tumor Necrosis Factor Alpha (TNF-α) level | 0 and 90 days | Level of TNF-α is obtained from laboratory test |
| Change of Interleukin 6 (IL-6) level | 0 and 90 days | Level of IL-6 is obtained from laboratory test |
| Change of Mayo score | 0 and 90 days | 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) |
| Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy | 0 and 90 days | Colon biopsy is obtained from colonoscopy and histopathology examination |
| Change of fecal calprotectin level | 0 and 90 days | Level of fecal calprotectin is obtained from stool examination |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AEs) | 30, 60 and 90 days | Number of participants with AE in this study |
| Number of participants with serious adverse events (SAEs) | 30, 60 and 90 days | Number of participants with SAEs in this study |
Countries
Indonesia
Contacts
Primary ContactMarcellus Simadibrata
Outcome results
None listed