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

U

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

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

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Marcellus Simadibrata

Data sourced from clinicaltrials.gov

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