The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).
Compound danshen dripping pills is a kind of traditional Chinese medicine(TCM), consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol. This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis), when compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo
Time frame: 24weeks
Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo
Time frame: 24 weeks.
Corrected visual acuity change from baseline at the end of week 24 compared to placebo
Time frame: 24 weeks.
The severity of macular edema change from baseline at the end of week 24 compared to placebo
Time frame: 24weeks
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Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Henan Institute of Ophthalmology
Zhengzhou, Henan, China
Hubei Provincial Hospital of TCM
Wuhan, Hubei, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China
Jiangsu Province Hospital of TCM
Nanjing, Jiangsu, China
...and 6 more locations