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

NCT ID: NCT04029649

Last Updated: 2019-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsule three times daily for 90 days

Interventions

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

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

Intervention Type DRUG

Placebo

Placebo capsule three times daily for 90 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Marcellus Simadibrata, Prof. PhD., SpPD, KGEH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcellus Simadibrata

Role: PRINCIPAL_INVESTIGATOR

Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia

Locations

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RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta, Jakarta Pusat, Indonesia

Site Status

Countries

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Indonesia

Central Contacts

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Marcellus Simadibrata

Role: CONTACT

0816920448

Facility Contacts

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Marcellus Simadibrata

Role: primary

0816920448

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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19-01-0083

Identifier Type: -

Identifier Source: org_study_id

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