A Multicenter, Randomized, Double Blind, Controlled Trial for Zhixue Quyu Mingmu Tablets and Compound Xue-shuan-tong Capsule in the Treatment of Retinal Vein Occlusion Patients with Blood Stasis and Yin Deficiency Syndrome

Phase 4

Completed

• Conditions: Retinal vein occlusion

• Registration Number: ITMCTR2000003323
• Lead Sponsor: Guang'anmen Hospital, Chinese Academy of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) The patients who met the western medicine diagnosis standard of retinal vein occlusion and had definite bleeding;
(2) Those who meet the syndrome differentiation criteria of blood stasis and collateral injury, yin deficiency and internal heat;
(3) Patients within 3 months (excluding 3 months);
(4) 35-75 years old;
(5) Signing informed consent.

Exclusion Criteria

(1) Patients with retinal vein occlusion and blood deficiency;
(2) The area of capillaries without perfusion of retinal vein occlusion was more than 5 disc diameters (PD) with neovascularization of disc, retina and iris, or the patients were treated by intraocular injection and laser therapy in the early stage;
(3) Patients with diabetic retinopathy, retinal detachment, proliferative retinopathy, senile maculopathy, glaucoma, severe cataract, inflammatory retinopathy and other eye diseases that affect the efficacy judgment;
(4) Eyeground hemorrhage caused by leukemia, trauma and other reasons;
(5) Pregnant, preparing pregnant or lactating women;
(6) Allergic constitution, especially allergic to fluorescein sodium injection;
(7) Patients with hypertension but still high blood pressure (systolic blood pressure >=160 or diastolic blood pressure >=100mmhg), severe cardiopulmonary insufficiency and severe arrhythmia (rapid atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, type II and III atrioventricular block, etc.) after drug treatment;
(8) In the patients with severe liver and kidney dysfunction, ALT and AST were more than 1.5 times of the upper limit of normal, Cr was more than 1.2 times of the upper limit of normal;
(9) Patients with severe primary diseases such as digestive system and hematopoietic system;
(10) Disabled patients (blind, deaf, dumb, mental disorders, mental disorders, etc.) as prescribed by law;
(11) Those who participated in other clinical trials in the past 3 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual effect;Improvement of the area of eyeground bleeding;

Secondary Outcome Measures

Name	Time	Method
Improvement of macular fovea thickness and total volume;TCM syndrome;Evaluation of neovascularization;Retinal circulation time of fundus fluorescein angiography;Evaluation of area without perfusion;