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Gypenosides Treatment for Optic Neuritis

Primary Purpose

Optic Neuritis

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gypenosides
Placebo
Sponsored by
First Affiliated Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring Neuroprotection, Clinical trial, Traditional Chinese medicine, Axonal loss, Jiaogulan, Gynostemma pentaphyllum, Optical coherence tomography

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. Male and female Chinese patients aged ≥18 to ≤60 years
  2. Patients with a first episode of optic neuritis in the eye of interest
  3. First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
  4. Best corrected visual acuity in the eye of interest ≤0.8

Exclusion criteria

  1. Pre-existing multiple sclerosis MS or NMO
  2. Refractive media opacity
  3. Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters
  4. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
  5. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
  6. Existing other retina or optic nerve diseases
  7. Pregnant or females who plan to be pregnant during study

Sites / Locations

  • The First Affiliated Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gypenosides

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean retinal nerve fibre layer thickness

Secondary Outcome Measures

Total macular volume
Best corrected visual acuity
Latency and amplitude of visual evoked potentials
Mean visual field defect
Number of participants with Adverse events

Full Information

First Posted
November 24, 2016
Last Updated
April 7, 2021
Sponsor
First Affiliated Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02976766
Brief Title
Gypenosides Treatment for Optic Neuritis
Official Title
Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Low enrolment
Study Start Date
February 4, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether gypenosides are neuroprotective in patients with acute optic neuritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
Keywords
Neuroprotection, Clinical trial, Traditional Chinese medicine, Axonal loss, Jiaogulan, Gynostemma pentaphyllum, Optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gypenosides
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gypenosides
Other Intervention Name(s)
Jiaogulan Zongdai
Intervention Description
Participants will receive gypenosides 360 mg/day (120 mg three times a day) for 10 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo three times a day for 10 days.
Primary Outcome Measure Information:
Title
Mean retinal nerve fibre layer thickness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total macular volume
Time Frame
6 months
Title
Best corrected visual acuity
Time Frame
6 months
Title
Latency and amplitude of visual evoked potentials
Time Frame
6 months
Title
Mean visual field defect
Time Frame
6 months
Title
Number of participants with Adverse events
Time Frame
Screening until end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Male and female Chinese patients aged ≥18 to ≤60 years Patients with a first episode of optic neuritis in the eye of interest First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product Best corrected visual acuity in the eye of interest ≤0.8 Exclusion criteria Pre-existing multiple sclerosis MS or NMO Refractive media opacity Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc) Existing other retina or optic nerve diseases Pregnant or females who plan to be pregnant during study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Du, MD
Organizational Affiliation
The First Affiliated Hospital of Guangxi Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China

12. IPD Sharing Statement

Learn more about this trial

Gypenosides Treatment for Optic Neuritis

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