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

July 31, 2019 updated by: Marcellus Simadibrata, Prof. PhD., SpPD, KGEH, Fakultas Kedokteran Universitas Indonesia

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

204

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Jakarta Pusat
      • Jakarta, Jakarta Pusat, Indonesia, 10430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
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
Placebo capsule three times daily for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life: SF-36 questionnaire
Time Frame: 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
0 and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of C-Reactive Protein (CRP) level
Time Frame: 0 and 90 days
Level of CRP is obtained from laboratory test.
0 and 90 days
Change of Erythrocyte Sedimentation Rate (ESR)
Time Frame: 0 and 90 days
ESR is obtained from laboratory test.
0 and 90 days
Change of Tumor Necrosis Factor Alpha (TNF-α) level
Time Frame: 0 and 90 days
Level of TNF-α is obtained from laboratory test
0 and 90 days
Change of Interleukin 6 (IL-6) level
Time Frame: 0 and 90 days
Level of IL-6 is obtained from laboratory test
0 and 90 days
Change of fecal calprotectin level
Time Frame: 0 and 90 days
Level of fecal calprotectin is obtained from stool examination
0 and 90 days
Change of Mayo score
Time Frame: 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)
0 and 90 days
Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy
Time Frame: 0 and 90 days
Colon biopsy is obtained from colonoscopy and histopathology examination
0 and 90 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs)
Time Frame: 30, 60 and 90 days
Number of participants with AE in this study
30, 60 and 90 days
Number of participants with serious adverse events (SAEs)
Time Frame: 30, 60 and 90 days
Number of participants with SAEs in this study
30, 60 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marcellus Simadibrata, Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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