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

University of Indonesia (UI)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: Beta-1,3/1,6-D-Glucan

Study type: Interventional

Funder types: Other

Identifiers

NCT04029649

19-01-0083

Details and patient eligibility

About

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

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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204 participants in 2 patient groups, including a placebo group

Beta-1,3/1,6-D-Glucan Ganoderma lucidum

Experimental group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo