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

Primary Purpose

Ulcerative Colitis

Status
Unknown status
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Beta-1,3/1,6-D-Glucan
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Beta-1,3/1,6-D-Glucan, Ganoderma lucidum, Ulcerative colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

Change in Quality of Life: SF-36 questionnaire
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

Secondary Outcome Measures

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

Full Information

First Posted
July 17, 2019
Last Updated
July 31, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT04029649
Brief Title
Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Beta-1,3/1,6-D-Glucan, Ganoderma lucidum, Ulcerative colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beta-1,3/1,6-D-Glucan Ganoderma lucidum
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group received empty capsule with dose 3x1 capsule a day for 90 days
Intervention Type
Drug
Intervention Name(s)
Beta-1,3/1,6-D-Glucan
Intervention Description
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule three times daily for 90 days
Primary Outcome Measure Information:
Title
Change in Quality of Life: SF-36 questionnaire
Description
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
Time Frame
0 and 90 days
Secondary Outcome Measure Information:
Title
Change of C-Reactive Protein (CRP) level
Description
Level of CRP is obtained from laboratory test.
Time Frame
0 and 90 days
Title
Change of Erythrocyte Sedimentation Rate (ESR)
Description
ESR is obtained from laboratory test.
Time Frame
0 and 90 days
Title
Change of Tumor Necrosis Factor Alpha (TNF-α) level
Description
Level of TNF-α is obtained from laboratory test
Time Frame
0 and 90 days
Title
Change of Interleukin 6 (IL-6) level
Description
Level of IL-6 is obtained from laboratory test
Time Frame
0 and 90 days
Title
Change of fecal calprotectin level
Description
Level of fecal calprotectin is obtained from stool examination
Time Frame
0 and 90 days
Title
Change of Mayo score
Description
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)
Time Frame
0 and 90 days
Title
Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy
Description
Colon biopsy is obtained from colonoscopy and histopathology examination
Time Frame
0 and 90 days
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events (AEs)
Description
Number of participants with AE in this study
Time Frame
30, 60 and 90 days
Title
Number of participants with serious adverse events (SAEs)
Description
Number of participants with SAEs in this study
Time Frame
30, 60 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcellus Simadibrata
Phone
0816920448
Email
marcellussimadibrata57@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcellus Simadibrata
Organizational Affiliation
Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
City
Jakarta
State/Province
Jakarta Pusat
ZIP/Postal Code
10430
Country
Indonesia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcellus Simadibrata
Phone
0816920448
Email
marcellussimadibrata57@gmail.com

12. IPD Sharing Statement

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

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