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

Sponsor

Fakultas Kedokteran Universitas Indonesia (Other)

Overall Status

Unknown status

CT.gov ID

NCT04029649

Collaborator

(none)

204

Enrollment

Location

Arms

Anticipated Duration (Months)

12.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Drug: Beta-1,3/1,6-D-Glucan Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

204 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Beta-1,3/1,6-D-Glucan Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Placebo Comparator: Placebo This group received empty capsule with dose 3x1 capsule a day for 90 days	Drug: Placebo Placebo capsule three times daily for 90 days

Arm

Intervention/Treatment

Experimental: 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

Drug: Beta-1,3/1,6-D-Glucan

Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days

Placebo Comparator: Placebo

This group received empty capsule with dose 3x1 capsule a day for 90 days

Drug: Placebo

Placebo capsule three times daily for 90 days

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 fecal calprotectin level [0 and 90 days]
Level of fecal calprotectin is obtained from stool examination
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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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