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

NCT ID: NCT04162314

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebos

Interventions

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

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

Intervention Type DRUG

Placebos

Placebos

Intervention Type DRUG

Other Intervention Names

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PsP

Eligibility Criteria

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Inclusion Criteria

1. Patients with non-infectious and idiopathic uveitis.
2. Indicated to receive oral steroid and have signs of anterior segment inflammation.
3. Anterior chamber inflammation \>= +2 according to SUN criteria.
4. 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

1. Received systemic steroid and/other immunosuppressive drugs two weeks before the start of the trial.
2. Received antibiotics one week before the start of the trial.
3. Contraindicated to oral steroid.
4. Other primary ocular disorder, such as glaucoma, anterior segment dysgenesis, or others.
5. Pregnant and nursing women.
6. Patients with history of hypersensitivity/ allergy to Ganoderma species or other fungi.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Hasianalumban

Ophthalmology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukman Edwar, SpM(K), Dr

Role: PRINCIPAL_INVESTIGATOR

FKUI/RSCM

Locations

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RSCM Kirana

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Hasiana Lumban Gaol, MD

Role: CONTACT

817200249 ext. +62

Lukman Edwar, SpM(K), Dr

Role: CONTACT

811845804 ext. +62

Facility Contacts

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Hasiana Lumban Gaol, MD

Role: primary

+62817200249

Other Identifiers

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19-08-1046

Identifier Type: -

Identifier Source: org_study_id

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