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Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Non-infectious and Idiopathic Uveitis

Primary Purpose

Uveitis

Status

Unknown status

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

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

Placebos

About this trial

This is an interventional treatment trial for Uveitis focused on measuring non-infectious uveitis, idiopathic uveitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

RSCM KiranaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

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

This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days

Outcomes

Primary Outcome Measures

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).

Change of serum TNF-alpha level

Secondary Outcome Measures

Full Information

NCT ID

NCT04162314

First Posted

November 6, 2019

Last Updated

February 1, 2021

Sponsor

Fakultas Kedokteran Universitas Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT04162314

Brief Title

Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Non-infectious and Idiopathic Uveitis

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 21, 2020 (Actual)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

December 2021 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis

Keywords

non-infectious uveitis, idiopathic uveitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

PsP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Placebos

Primary Outcome Measure Information:

Title

Change in anterior chamber inflammatory cells grading

Description

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).

Time Frame

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

Title

Change of serum TNF-alpha level

Description

Change of serum TNF-alpha level

Time Frame

Baseline, week-6, month-3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hasiana Lumban Gaol, MD

Phone

817200249

Ext

+62

hasiana.lumbangaol@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lukman Edwar, SpM(K), Dr

Phone

811845804

Ext

+62

lukmanedwar@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lukman Edwar, SpM(K), Dr

Organizational Affiliation

FKUI/RSCM

Official's Role

Principal Investigator

Facility Information:

Facility Name

RSCM Kirana

City

Jakarta Pusat

State/Province

DKI Jakarta

ZIP/Postal Code

10320

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hasiana Lumban Gaol, MD

Phone

+62817200249

hasiana.lumbangaol@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Non-infectious and Idiopathic Uveitis

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