A Phase 2 interventional study of Gypenosides and Placebo in Optic Neuritis, sponsored by First Affiliated Hospital of Guangxi Medical University. Terminated at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by First Affiliated Hospital of Guangxi Medical University · Phase 2, Interventional, and Treatment
This pilot randomized, double-blind, placebo-controlled trial evaluated whether short-course adjunctive gypenosides, added to standard corticosteroid treatment, may preserve retinal structural outcomes in adults with acute optic neuritis.
This was a single-center, randomized, double-blind, placebo-controlled pilot trial in adults with a first episode of acute optic neuritis within 28 days of symptom onset. Participants received standard corticosteroid treatment and were randomized in a 1:1 ratio to adjunctive oral gypenosides 180 mg/day for 10 days or matching placebo.
The trial was designed as a pilot study to estimate structural treatment effects and variability for future neuroprotection trials in optic neuritis. The primary structural outcome was peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6 measured by spectral-domain OCT. Secondary outcomes included total macular volume, best-corrected visual acuity, visual evoked potentials, visual-field measures, and safety outcomes.
Macular ganglion cell-inner plexiform layer thickness was analyzed as an exploratory segmentation-derived macular structural endpoint.
Baseline aquaporin 4 immunoglobulin G serostatus was assessed. Myelin oligodendrocyte glycoprotein immunoglobulin G testing was not included in the original study design.
88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 58 interventional studies indexed under Optic Neuritis.
Browse Optic Neuritis studies →First Affiliated Hospital of Guangxi Medical University is the lead sponsor of 41 studies on the registry; 25 are open to participants now.
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Exclusion criteria
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received adjunctive oral gypenosides for 10 days in addition to standard corticosteroid treatment.
Drug: Gypenosides
Participants received matching placebo capsules for 10 days in addition to standard corticosteroid treatment.
Drug: Placebo
Participants received gypenosides 180 mg/day, given as 60 mg three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment.
Also known as: Jiaogulan Zongdai
Participants received matching placebo capsules three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment.
Mean peripapillary retinal nerve fiber layer thickness
Peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6, measured in micrometers by spectral-domain OCT. The index eye was the affected study eye; in bilateral cases, the eye with worse baseline best-corrected visual acuity was used, and if visual acuity was equal, the right eye was used. Higher values indicate less retinal nerve fiber layer thinning.
Time frame: 6 months
Total macular volume
Total macular volume in the prespecified index eye at Month 6, measured by spectral-domain OCT macular volume scans. Higher values indicate greater macular volume. Macular ganglion cell-inner plexiform layer thickness was not a registered secondary outcome and was analyzed only as an exploratory segmentation-derived macular structural endpoint.
Time frame: 6 months
Best-corrected visual acuity
Best-corrected visual acuity in the prespecified index eye at Month 6, assessed using a high-contrast tumbling-E chart and converted to logarithm of the minimum angle of resolution for analysis.
Time frame: 6 months
Latency and amplitude of visual evoked potentials
Pattern-reversal visual evoked potentials in the prespecified index eye at Month 6. P100 latency was measured in milliseconds, and N75-P100 peak-to-peak amplitude was measured in microvolts.
Time frame: 6 months
Mean visual field defect
Visual-field mean defect or mean deviation in the prespecified index eye at Month 6, measured in decibels using automated perimetry.
Time frame: 6 months
Number of participants with adverse events
Number of participants with adverse events or serious adverse events from screening through the end of study follow-up. Relationship to study medication was assessed by investigators.
Time frame: Screening until end of study
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Guangxi Medical University