Nonischemic Retinal Vein Occlusion (Syndrome of Static Blood Blocking Collaterals)
Conditions
Interventions
high-dose group:Xuesaitong Soft Capsules
low-dose group:Xuesaitong Soft Capsules and Xuesaitong Soft Capsules simulants
Control group:Xuesaitong Soft Capsules simulants (placebo)
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be eligible for this clinical trial, subjects must meet all of the following criteria: 1. Subjects must have documented history of nonischemic retinal vein occlusion(including the central retinal vein occlusion,CRVO and branch retinal vein occlusion, BRVO) according to Western medicine diagnostic criteria; 2. Subjects must have documented history of syndrome of static blood blocking collaterals according to Chinese medicine diagnostic criteria; 3. Retinal non-perfusion area <5 papillary diameter, PD; 4. Study eye central macular thickness,CMT <250µm observed by OCT; 5. The course of disease <3 months; 6. Study eye best corrected visual acuity,BCVA=0.1and =0.5(equal to Snellen=20/200 and = 20/40); 7. Subjects must be =35-years-old and =75-years-old (including 35-years-old and 75-years-old), both male and female are allowed; 8. Subjects must provide informed consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are ineligible for enrollment in the clinical trial: 1. Subjects who have documented history of ischemic retinal vein occlusion, RVO; 2. Subjects whose RVO capillary accumulated non-perfusion area >5PD, with associated complications of retinal, disc, iris neovascularization or those who have accepted intraocular injection, laser surgery or other therapies in the earlier stage of this clinical trial; 3. Subjects with ocular diseases who have associated complications of diabetic retinopathy, retinal detachment, proliferative retinopathy, age-related maculopathy, glaucoma, severe cataract, or retinal vasculopathy caused by inflammation that will impair the judgement of efficacy; 4. Subjects combined serious primary diseases in heart, brain, liver, kidney, hemopoietic system and endocrine system with dysfunction; ALT, AST>1.5 times of upper normal limit or Cr>upper normal limit; 5. Subjects who are unstable in diabetes blood sugar control with fasting blood glucose >11.1mmol/L, or requiring drug control for diabetic complications such as diabetic nephropathy and peripheral neuropathy; 6. Subjects with severe hypertension disease whose systolic blood pressure,SBP=160mmHg and diastolic blood pressure, DBP>90mmHg after taking antihypertensive drugsor subjects with hypotension disease whose sitting systolic blood pressure, SBP=90mmHg and diastolic blood pressure, DBP=50mmHg; 7. Subjects with disabilities stipulated by law, including the blind, deaf, dumb and those with dysnoesia, mental disturbance and physical disability; 8. Subjects who are alcohol dependent or have history of drug abuse; 9. Women who are pregnant, breastfeeding or planning for pregnancy during the course of this trial; 10. Subjects with allergic constitution or with known allergies to more than one drug, or those allergic to fluorescein sodium or any ingredient contained in test drugs of ginseng and panax notoginseng; 11. Subjects who have participated in other clinical trials 3 months prior to this trial; 12. Subjects who, in investigators judgement, are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity,BCVA change situation compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fundus hemorrhage area;Central macular thickness,CMT;Non-perfusion area (calculated by papillary diameter,PD);retinal circulation time(filling delay time);occurrence rate of neovascularization;Hemorheology:whole blood high shear viscosity, whole blood low shear viscosity, plasma viscosity, erythrocyte sedimentation rate;Effect on the TCM syndrome; | — |
Countries
China
Contacts
Public ContactJiajun Xu
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Outcome results
None listed