- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029649
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
Intervention / Treatment
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
- Name: Marcellus Simadibrata
- Phone Number: 0816920448
- Email: marcellussimadibrata57@gmail.com
Study Locations
-
-
Jakarta Pusat
-
Jakarta, Jakarta Pusat, Indonesia, 10430
- RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
-
Contact:
- Marcellus Simadibrata
- Phone Number: 0816920448
- Email: marcellussimadibrata57@gmail.com
-
-
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
Additional Relevant MeSH Terms
Other Study ID 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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