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

Uveitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04162314
• Other study ID #: 19-08-1046
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 21, 2020
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Hasiana Lumban Gaol, MD
• Phone: 817200249
• Email: hasiana.lumbangaol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Beta-1,3/1,6-D-Glucan Ganoderma lucidum
Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
• Placebos
Placebos

Locations

Country	Name	City	State
Indonesia	RSCM Kirana	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of serum TNF-alpha level	Change of serum TNF-alpha level	Baseline, week-6, month-3