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

Sponsor
Fakultas Kedokteran Universitas Indonesia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04162314
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
22.3
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Beta-1,3/1,6-D-Glucan Ganoderma lucidum
  • Drug: Placebos
 Phase 2/Phase 3

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 21, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in anterior chamber inflammatory cells grading [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).

    2. Change of serum TNF-alpha level [Baseline, week-6, month-3]

      Change of serum TNF-alpha level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 RSCM Kirana Jakarta Pusat DKI Jakarta Indonesia 10320

    Sponsors and Collaborators

    • Fakultas Kedokteran Universitas Indonesia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hasianalumban, Ophthalmology resident, Fakultas Kedokteran Universitas Indonesia
    ClinicalTrials.gov Identifier:
    NCT04162314
    Other Study ID Numbers:
    • 19-08-1046
    First Posted:
    Nov 14, 2019
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hasianalumban, Ophthalmology resident, Fakultas Kedokteran Universitas Indonesia
    non-infectious uveitis
    idiopathic uveitis
    Additional relevant MeSH terms:
    Uveitis

    Study Results

    No Results Posted as of Feb 3, 2021