Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy
- Conditions
- Non-proliferative Diabetic Retinopathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT02388984
- Lead Sponsor
- Tasly Pharmaceuticals, Inc.
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 480
- Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis.
- aged 30-70 years
- voluntary signs the informed consent
One eye met the inclusion criteria can be used as research object, if both eyes met the inclusion criteria, please record respectively, and select one eye for efficacy evaluation with reference to the following principles:
When the two eyes of fundus conditions in different clinical stage, choose the more serious one.
When the two eyes of fundus conditions in the same clinical stage, choose the eye easier for clinical operation.
- HbAlc>8%, sustained hyperglycemia.
- The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes).
- Diabetic retinopathy caused by type 1 diabetes mellitus.
- Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
- Combined with primarily severe diseases such as cardiovascular, hepatic，renal illness , hemopoietic system disease, and psychosis. Serum transaminase is higher than the limit of normal value of 1.5 times.
- Diabetic nephropathy with renal failure (Azotemia or Uremia).
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant. Having any allergic reaction to some drugs.
- Participated in other clinical trial within 3 months.
- Used drugs for the treatment of diabetic retinopathy within 1 week.
- Blood pressure > 160/100 (systolic above 160 or diastolic above 100).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo,20pills,tid. Duration: 24 weeks. Compound danshen dripping pills Compound danshen dripping pills Compound danshen dripping pills,20pills,tid. Duration: 24 weeks.
- Primary Outcome Measures
Name Time Method The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo 24weeks
- Secondary Outcome Measures
Name Time Method Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo 24 weeks. Corrected visual acuity change from baseline at the end of week 24 compared to placebo 24 weeks. The severity of macular edema change from baseline at the end of week 24 compared to placebo 24weeks
Trial Locations
- Locations (16)
The First Affiliated Hospital of Guangzhou University of TCM
🇨🇳Guang Zhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nan Ning, Guangxi, China
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
🇨🇳Bei Jing, Beijing, China
Hubei Provincial Hospital of TCM
🇨🇳Wu Han, Hubei, China
The First Hospital of Hunan University of Chinese Medicine
🇨🇳Chang Sha, Hunan, China
Jiangsu Province Hospital of TCM
🇨🇳Nan Jing, Jiangsu, China
The Affiliated Hospital of Changchun University of Chinese Medicine
🇨🇳Chang Chun, Jilin, China
Dongfang Hospital, Beijing University of Chinese Medicine
🇨🇳Bei Jing, Beijing, China
Southwest Hospital, Third Military Medical University
🇨🇳Chong Qing, Chongqing, China
Jiangxi Provincial People's Hospital
🇨🇳Nan Chang, Jiangxi, China
Shenyang He Eye Hospital
🇨🇳Shen Yang, Liaoning, China
Henan Institute of Ophthalmology
🇨🇳Zheng Zhou, Henan, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
🇨🇳Wu Han, Hubei, China
Shanghai General Hospital
🇨🇳Shang Hai, Shanghai, China
Yantai Yuhuangding Hospital
🇨🇳Yan Tai, Shandong, China
Teaching Hospital of Chengdu University of TCM
🇨🇳Cheng Du, Sichuan, China