UveitisPhase 2/3NCT04162314
Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Non-infectious and Idiopathic Uveitis
A Phase 2/3 study testing Beta-1,3/1,6-D-Glucan Ganoderma lucidum in people with Uveitis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
Trial summary
To investigate the effect of Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum as an adjuvant to methylprednisolone for non-infectious and idiopathic uveitis Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Uveitis
- What is being tested?
- Beta-1,3/1,6-D-Glucan Ganoderma lucidum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 21 Jan 2020to Dec 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with non-infectious and idiopathic uveitis.
- Indicated to receive oral steroid and have signs of anterior segment inflammation.
- Anterior chamber inflammation >= +2 according to SUN criteria.
- Age between 18 and 65 years old, good general condition, consented to be involved in the research, and are willing to come regularly according to follow up schedule.
Who cannot join
- Received systemic steroid and/other immunosuppressive drugs two weeks before the start of the trial.
- Received antibiotics one week before the start of the trial.
- Contraindicated to oral steroid.
- Other primary ocular disorder, such as glaucoma, anterior segment dysgenesis, or others.
- Pregnant and nursing women.
- Patients with history of hypersensitivity/ allergy to Ganoderma species or other fungi.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSCM Kirana
Jakarta Pusat, DKI Jakarta, 10320
Hasiana Lumban Gaol, MD, +62817200249, hasiana.lumbangaol@gmail.com
About this study
Official title: The Role of β-1,3/1,6-D-Glucan From Extract of Indonesian Ganoderma Lucidum Mycelium as a Combination Therapy With Methylprednisolone for Treatment of Non-infectious and Idiopathic Uveitis: A Double-blind Randomized Pilot Study
To investigate the effect of Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum as an adjuvant to methylprednisolone for non-infectious and idiopathic uveitis
Read the detailed description
Patients with non-infectious and idiopathic uveitis will receive standard treatment with methylprednisolone, but will be randomized to receive either Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum or placebo. Follow up will be performed on week-2, week-4, week-6, month-2, and month-3. Outcomes measured are anterior chamber cells, visual acuity, and serum TNF-alpha levels.
- Conditions
- Uveitis
- Being tested
- Beta-1,3/1,6-D-Glucan Ganoderma lucidum, Placebos
- Keywords
- non-infectious uveitis, idiopathic uveitis
- Medical subject headings
- Uveitis
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-Glucan Ganoderma lucidumDrug
Also called PsP
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
PlacebosDrug
Placebos
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | This group received combination of mycelium extract of Ganoderma lucidum capsule containing 180 mg Beta-1,3/1,6-D-Glucan with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days Receives: Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidum |
| Control | Placebo comparator | This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anterior chamber inflammatory cells grading
Change in anterior chamber inflammatory cells grading according to SUN nomenclature (0, 0.5+, 1+, 2+, 3+, 4+). 0 is minimum value (better outcome) and +4 is maximum value (worse outcome).
Measured: Baseline, week-2, week-4, week-6, month-2, month-3
Change of serum TNF-alpha level
Change of serum TNF-alpha level
Measured: Baseline, week-6, month-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start21 Jan 2020
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasianalumban, Fakultas Kedokteran Universitas Indonesia
- Investigators
- Lukman Edwar, SpM(K), Dr, Principal investigator, FKUI/RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162314
- Sponsor's protocol ID
- 19-08-1046
- Status last verified
- Feb 2021
- First submitted
- 6 Nov 2019
- Last updated
- 3 Feb 2021
- 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 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of β-1,3/1,6-D-Glucan From Extract of Indonesian Ganoderma Lucidum Mycelium as a Combination Therapy With Methylprednisolone for Treatment of Non-infectious and Idiopathic Uveitis: A Double-blind Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04162314
- Acronym / sponsor ID
- 19-08-1046
- Conditions
- Uveitis
- Keywords
- non-infectious uveitis, idiopathic uveitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Nov 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.
To investigate the effect of Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum as an adjuvant to methylprednisolone for non-infectious and idiopathic uveitis
Detailed description
Patients with non-infectious and idiopathic uveitis will receive standard treatment with methylprednisolone, but will be randomized to receive either Beta-1,3/1,6-D-Glucan from mycelium extract of Indonesian Ganoderma lucidum or placebo. Follow up will be performed on week-2, week-4, week-6, month-2, and month-3. Outcomes measured are anterior chamber cells, visual acuity, and serum TNF-alpha levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidumThis group received combination of mycelium extract of Ganoderma lucidum capsule containing 180 mg Beta-1,3/1,6-D-Glucan with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days |
| Control | Placebo comparator | Drug: PlacebosThis group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with non-infectious and idiopathic uveitis.
- Indicated to receive oral steroid and have signs of anterior segment inflammation.
- Anterior chamber inflammation >= +2 according to SUN criteria.
- Age between 18 and 65 years old, good general condition, consented to be involved in the research, and are willing to come regularly according to follow up schedule.
Key exclusion criteria (6 listed)
- Received systemic steroid and/other immunosuppressive drugs two weeks before the start of the trial.
- Received antibiotics one week before the start of the trial.
- Contraindicated to oral steroid.
- Other primary ocular disorder, such as glaucoma, anterior segment dysgenesis, or others.
- Pregnant and nursing women.
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-Glucan Ganoderma lucidumAlso: PsPBeta-1,3/1,6-D-Glucan capsule three times daily for 90 days | Drug | Experimental |
| PlacebosPlacebos | Drug | Control |
Primary outcome
Change in anterior chamber inflammatory cells grading
Time frame: Baseline, week-2, week-4, week-6, month-2, month-3
Change in anterior chamber inflammatory cells grading according to SUN nomenclature (0, 0.5+, 1+, 2+, 3+, 4+). 0 is minimum value (better outcome) and +4 is maximum value (worse outcome).
Change of serum TNF-alpha level
Time frame: Baseline, week-6, month-3
Change of serum TNF-alpha level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
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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.
Lukman Edwar, SpM(K), Dr principal investigator
FKUI/RSCM
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 Ganoderma lucidum in people with Uveitis, 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 4 inclusion and 6 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 3 Feb 2021. 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 Hasiana Lumban Gaol, MD (817200249 ext. +62, hasiana.lumbangaol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anterior chamber inflammatory cells grading (time frame: Baseline, week-2, week-4, week-6, month-2, month-3). The study lists 2 primary outcomes in all. 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 3 Feb 2021.