Effect of Qizhijiangtang Capsule on treating Non-Proliferative Diabetic Retinopathy

Phase 1

• Conditions: on-Proliferative Diabetic Retinopathy

• Registration Number: ITMCTR1900002373
• Lead Sponsor: Guang'anmen Hospital, China Academy of 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. According to WHO criteria in 1999, meet the diagnosis of type 2 diabetes mellitus;
2. Meet the diagnosis of diabetic retinopathy, and the retinopathy is at non-proliferative phase;
3. Pattern differentiation of TCM is deficiency of qi and yin and blood stasis;
4. Aged 30-70 years;
5. Have signed the informed consent;
6. Hypoglycemic drugs have been used steadily in the past three months and can be expected to remain unchanged throughout the study.

Exclusion Criteria

1. Postoperative retinal photocoagulation, suitable photocoagulation therapy, diabetic retinopathy patients with proliferative stage of diabetic retinopathy (IV, V, VI stage), diabetic retinopathy patients with type 1 diabetes mellitus, patients with other eye diseases (e.g. glaucoma, cataracts that significantly affect fundus examination, non-diabetic retinopathy, uveitis, retinal detachment) Optic nerve diseases and high myopia with fundus diseases, etc.
2. Those with serious complications of heart, lung, liver, kidney and brain or with other serious primary diseases;
3. Recurrent hypoglycemia, diabetic ketosis, ketoacidosis and severe infections in recent months;
4. If the systolic blood pressure is greater than 160 mmHg or (and) the diastolic blood pressure is greater than 100 mmHg after uncontrolled or controlled blood pressure;
5. Diabetic nephropathy occurs in renal failure (azotemia, uremia);
6. Pregnant, pregnant or lactating women, or those with a history of drug allergy;
7. Psychiatric patients;
8. Patients with impaired liver and kidney function (ALT and AST were 2 times higher than the upper limit of normal value, and serum creatinine was higher than the upper limit of normal value).
9. Alcohol abuse and/or psychoactive substances, drug abusers and addicts in the past five years;
10. According to the judgement of the researcher, other pathological changes or situations that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment, unstable living environment and so on, are liable to lead to lost visits;
11. Allergic to any component of Qizhi Jiangtang Capsule.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
fundus photography;fundus fluorescein angiography;

Secondary Outcome Measures

Name	Time	Method
TCM symptoms;fasting blood glucose;routine ophthalmological examination;2h postprandial blood glucose;glycosylated hemoglobin;urine albumin excretion ratio;Blood lipids;