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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beta-1,3/1,6-D-Glucan Ganoderma lucidum | Experimental | 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 |
|
| Placebo | Placebo Comparator | This group received empty capsule with dose 3x1 capsule a day for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-1,3/1,6-D-Glucan | Drug | Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of C-Reactive Protein (CRP) level | Level of CRP is obtained from laboratory test. | 0 and 90 days |
| Change of Erythrocyte Sedimentation Rate (ESR) | ESR is obtained from laboratory test. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Number of participants with AE in this study | 30, 60 and 90 days |
| Number of participants with serious adverse events (SAEs) | Number of participants with SAEs in this study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcellus Simadibrata | Contact | 0816920448 | marcellussimadibrata57@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcellus Simadibrata | Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital) | Jakarta | Jakarta Pusat | 10430 | Indonesia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2019 | Jul 31, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo | Drug | Placebo capsule three times daily for 90 days |
|
| 0 and 90 days |
| Change of Tumor Necrosis Factor Alpha (TNF-α) level | Level of TNF-α is obtained from laboratory test | 0 and 90 days |
| Change of Interleukin 6 (IL-6) level | Level of IL-6 is obtained from laboratory test | 0 and 90 days |
| Change of fecal calprotectin level | Level of fecal calprotectin is obtained from stool examination | 0 and 90 days |
| 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) | 0 and 90 days |
| Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy | Colon biopsy is obtained from colonoscopy and histopathology examination | 0 and 90 days |
| 30, 60 and 90 days |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |