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

Phase 2

• Conditions: Ulcerative Colitis
• Interventions: Drug: Beta-1,3/1,6-D-Glucan; Drug: Placebo

• Registration Number: NCT04029649
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-23
• Last Update Submitted: 2019-07-31
• Study Start: 2019-08
• Last Update Posted: 2019-08-02
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta-1,3/1,6-D-Glucan Ganoderma lucidum	Beta-1,3/1,6-D-Glucan	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	This group received empty capsule with dose 3x1 capsule a day for 90 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change of fecal calprotectin level	0 and 90 days	Level of fecal calprotectin is obtained from stool examination
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

Trial Locations

Locations (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital); 🇮🇩 Jakarta, Jakarta Pusat, Indonesia