Effect of Ginkgo Biloba Capsule on Visual Function of Primary Open-angle Glaucoma With Blood Stasis Syndrome
1 other identifier
interventional
512
1 country
1
Brief Summary
Primary Open Angle Glaucoma (POAG) is an eye disease that causes optic nerve damage, visual field defect, and blindness caused by increased intraocular pressure. In recent years, many studies have shown that ginkgo biloba extract has a protective effect on the visual function of glaucoma patients. Studies have shown that Ginkgo biloba capsules can improve the visual field damage of glaucoma controlled by intraocular pressure;Ginkgo biloba capsule can promote the recovery of visual evoked potential of glaucoma controlled by intraocular pressure; the improvement of visual field has a certain correlation with visual electrophysiological recovery. The mechanism may be achieved by suppressing the influx of calcium ions and thereby inhibiting the apoptosis of cells. Therefore, in this clinical study, effect of Ginkgo biloba capsule on visual function of primary open-angle glaucoma with blood stasis syndrome was evaluated by placebo as control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2015
CompletedFirst Submitted
Initial submission to the registry
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedApril 6, 2020
April 1, 2020
5.5 years
April 1, 2020
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean defect of visual field (MD)
Detection by humphrey visual field meter
After 48 weeks of treatment
Secondary Outcomes (1)
Retinal nerve fiber layer thickness (RNFL)
After 12, 24, 36, and 48 weeks of treatment
Study Arms (2)
Test team
ACTIVE COMPARATORPatients were treated with ginkgo biloba capsule regularly. Take 2 capsules 3 times a day, orally
Control group
PLACEBO COMPARATORPatients were treated with placebo regularly.Take 2 capsules 3 times a day, orally
Interventions
Ginkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve.
Eligibility Criteria
You may qualify if:
- \. Accord with the diagnostic criteria of primary open-angle glaucoma.
- \. Accord with the standard of blood stasis and collateralization syndrome in traditional Chinese medicine (TCM).
- \. Intraocular pressure ≤ 18mmHg
- \. AGIS score of visual field defect ≥ 6 points and ≤ 17 points, cup to disc ratio \> 0.6, central corrected visual acuity ≥ 0.3.
You may not qualify if:
- \. The diagnoses of angle closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, high intraocular pressure (IOP) and secondary glaucoma.
- \. Patients with various fundus diseases, such as retinal detachment, retinal vein occlusion, retinal pigmented degeneration, blood or vascular diseases.
- \. Complicated with cornea, iris, visible lens lesion, or one-eye patient.
- \. Patients who need to use improved circulation, nutritional nerve drugs during the trial.
- \. Any eye surgery or laser therapy during the induction period.
- \. Patients with a history of eye infection during the introduction period.
- \. Complicated with severe liver and kidney diseases, or abnormal examination of liver and kidney function (ALT,AST ≥ normal upper limit 1.5 times, SCr \> normal upper limit).
- \. Complicated with severe heart and lung diseases (such as bronchial asthma or history of bronchial asthma, chronic obstructive pulmonary disease, bronchospasm, respiratory failure, etc.), diabetes, advanced tumors, blood and hematopoietic system diseases, or other serious or progressive diseases of the system.
- \. A person who is prone to bleeding, or who has suffered severe bleeding during the period of introduction.
- \. Pregnant, lactating women or recent birth plans.
- \. Other conditions considered inappropriate by the investigator.
- \. Patients who participated in other clinical trials during the introduction period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jian Ge, M.D,Ph.D
Zhognshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 6, 2020
Study Start
April 28, 2015
Primary Completion
October 30, 2020
Study Completion
November 30, 2020
Last Updated
April 6, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share
The archived documents and materials are not loaned. If the management department needs to access the original data, it should be agreed by the PI of the project.