NCT04162314

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1.6 years

First QC Date

November 6, 2019

Last Update Submit

February 1, 2021

Conditions

Uveitis

Keywords

non-infectious uveitisidiopathic uveitis

Outcome Measures

Primary Outcomes (2)

  • 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).

    Baseline, week-2, week-4, week-6, month-2, month-3

  • Change of serum TNF-alpha level

    Change of serum TNF-alpha level

    Baseline, week-6, month-3

Study Arms (2)

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

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

Drug: Placebos

Interventions

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

Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days

Also known as: PsP
Experimental
PlacebosDRUG

Placebos

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSCM Kirana

Jakarta Pusat, DKI Jakarta, 10320, Indonesia

RECRUITING

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Lukman Edwar, SpM(K), Dr

    FKUI/RSCM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasiana Lumban Gaol, MD

CONTACT

817200249hasiana.lumbangaol@gmail.com

Lukman Edwar, SpM(K), Dr

CONTACT

811845804lukmanedwar@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology resident

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 14, 2019

Study Start

January 21, 2020

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

ID(1)