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

February 1, 2021 updated by: Hasianalumban, Fakultas Kedokteran Universitas Indonesia

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
Other Names:
  • PsP
PLACEBO_COMPARATOR: Control
This group received combination of placebo capsules with 3x1 dosage and methylprednisolone (0.8 mg/kgBW) 1x1 for 90 days
Drug: Placebos
Placebos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, week-2, week-4, week-6, month-2, month-3
Change of serum TNF-alpha level
Time Frame: Baseline, week-6, month-3
Change of serum TNF-alpha level
Baseline, week-6, month-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fakultas Kedokteran Universitas Indonesia

Investigators

  • Principal Investigator: Lukman Edwar, SpM(K), Dr, FKUI/RSCM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (ACTUAL)

November 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-08-1046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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