Ulcerative ColitisPhase 2/3NCT04029649
Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis
A Phase 2/3 study testing Beta-1,3/1,6-D-Glucan in people with Ulcerative Colitis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Beta-1,3/1,6-D-Glucan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteIndonesia
- Study dates
- Aug 2019to Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years old
- ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
- agreed to participate in this study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta, Jakarta Pusat, 10430
Marcellus Simadibrata, 0816920448, marcellussimadibrata57@gmail.com
About this study
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
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
- Conditions
- Ulcerative Colitis
- Being tested
- Beta-1,3/1,6-D-Glucan, Placebo
- Keywords
- Beta-1,3/1,6-D-Glucan, Ganoderma lucidum, Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-1,3/1,6-D-GlucanDrug
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
PlaceboDrug
Placebo capsule three times daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Beta-1,3/1,6-D-Glucan Ganoderma lucidum | Experimental | 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 Receives: Drug: Beta-1,3/1,6-D-Glucan |
| Placebo | Placebo comparator | This group received empty capsule with dose 3x1 capsule a day for 90 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 and 90 days
Secondary outcomes (7)
Change of C-Reactive Protein (CRP) level
Level of CRP is obtained from laboratory test.
Measured: 0 and 90 days
Change of Erythrocyte Sedimentation Rate (ESR)
ESR is obtained from laboratory test.
Measured: 0 and 90 days
Change of Tumor Necrosis Factor Alpha (TNF-α) level
Level of TNF-α is obtained from laboratory test
Measured: 0 and 90 days
Change of Interleukin 6 (IL-6) level
Level of IL-6 is obtained from laboratory test
Measured: 0 and 90 days
Change of fecal calprotectin level
Level of fecal calprotectin is obtained from stool examination
Measured: 0 and 90 days
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)
Measured: 0 and 90 days
Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy
Colon biopsy is obtained from colonoscopy and histopathology examination
Measured: 0 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcellus Simadibrata, Prof. PhD., SpPD, KGEH, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Marcellus Simadibrata, Principal investigator, Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029649
- Sponsor's protocol ID
- 19-01-0083
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04029649
- Acronym / sponsor ID
- 19-01-0083
- Conditions
- Ulcerative Colitis
- Keywords
- Beta-1,3/1,6-D-Glucan, Ganoderma lucidum, Ulcerative colitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-1,3/1,6-D-Glucan Ganoderma lucidum | Experimental | Drug: Beta-1,3/1,6-D-GlucanThis 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 |
| Placebo | Placebo comparator | Drug: PlaceboThis group received empty capsule with dose 3x1 capsule a day for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years old
- ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
- agreed to participate in this study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-1,3/1,6-D-GlucanBeta-1,3/1,6-D-Glucan capsule three times daily for 90 days | Drug | Beta-1,3/1,6-D-Glucan Ganoderma lucidum |
| PlaceboPlacebo capsule three times daily for 90 days | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Change of C-Reactive Protein (CRP) level
Time frame: 0 and 90 days
Change of Erythrocyte Sedimentation Rate (ESR)
Time frame: 0 and 90 days
Change of Tumor Necrosis Factor Alpha (TNF-α) level
Time frame: 0 and 90 days
Change of Interleukin 6 (IL-6) level
Time frame: 0 and 90 days
Change of fecal calprotectin level
Time frame: 0 and 90 days
Change of Mayo score
Time frame: 0 and 90 days
Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy
Time frame: 0 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
Related trials for Ulcerative Colitis
Active, not recruitingPhase 2/3
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Active, not recruitingPhase 2
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, Ulcerative
Active, not recruitingPhase 3
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Colitis, Ulcerative
RecruitingPhase 2
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
Ulcerative Colitis
RecruitingPhase 2
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Colitis, Ulcerative, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcellus Simadibrata principal investigator
Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Beta-1,3/1,6-D-Glucan in people with Ulcerative Colitis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcellus Simadibrata (0816920448, marcellussimadibrata57@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life: SF-36 questionnaire (time frame: 0 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.