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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Indonesia
    • Jakarta Pusat
      • Jakarta, Jakarta Pusat, Indonesia, 10430
        • RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Beta-1,3/1,6-D-Glucan
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
Drug: Placebo
Placebo capsule three times daily for 90 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fakultas Kedokteran Universitas Indonesia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-01-0083

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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