Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Beta-1,3/1,6-D-Glucan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta-1,3/1,6-D-Glucan Ganoderma lucidum<br>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 | Drug: Beta-1,3/1,6-D-Glucan<br>* Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days<br>|
| Placebo Comparator: Placebo<br>This group received empty capsule with dose 3x1 capsule a day for 90 days | Drug: Placebo<br>* Placebo capsule three times daily for 90 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Beta-1,3/1,6-D-Glucan, Ganoderma lucidum, Ulcerative colitis