Clinical trial NCT02388984: Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy
Official title: A Randomized, Double Blind, Multi-Center Study of Compound Danshen Dripping Pills in Patients With Diabetic Retinopathy (Syndrome Of Qi-Stagnation and Blood Stasis)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-proliferative Diabetic Retinopathy
Lead sponsor: Tasly Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 480
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis.
2. aged 30-70 years
3. 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.

Exclusion Criteria:

1. HbAlc\>8%, sustained hyperglycemia.
2. The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes).
3. Diabetic retinopathy caused by type 1 diabetes mellitus.
4. Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
5. 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.
6. Diabetic nephropathy with renal failure (Azotemia or Uremia).
7. For women of child-bearing potential: pregnant or lactating or intending to become pregnant. Having any allergic reaction to some drugs.
8. Participated in other clinical trial within 3 months.
9. Used drugs for the treatment of diabetic retinopathy within 1 week.
10. Blood pressure \> 160/100 (systolic above 160 or diastolic above 100).

Primary outcomes:
measure: The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo
timeFrame: 24weeks
Secondary outcomes:
measure: Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo
timeFrame: 24 weeks.
measure: Corrected visual acuity change from baseline at the end of week 24 compared to placebo
timeFrame: 24 weeks.
measure: The severity of macular edema change from baseline at the end of week 24 compared to placebo
timeFrame: 24weeks
Other outcomes:
Locations:
city: Bei Jing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
city: Bei Jing
country: China
facility: Dongfang Hospital, Beijing University of Chinese Medicine
state: Beijing
city: Chong Qing
country: China
facility: Southwest Hospital, Third Military Medical University
state: Chongqing
city: Guang Zhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of TCM
state: Guangdong
city: Nan Ning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Zheng Zhou
country: China
facility: Henan Institute of Ophthalmology
state: Henan
city: Wu Han
country: China
facility: Hubei Provincial Hospital of TCM
state: Hubei
city: Wu Han
country: China
facility: Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
state: Hubei
city: Chang Sha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Nan Jing
country: China
facility: Jiangsu Province Hospital of TCM
state: Jiangsu
city: Nan Chang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Chang Chun
country: China
facility: The Affiliated Hospital of Changchun University of Chinese Medicine
state: Jilin
city: Shen Yang
country: China
facility: Shenyang He Eye Hospital
state: Liaoning
city: Yan Tai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shang Hai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Cheng Du
country: China
facility: Teaching Hospital of Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Tasly Group, Co. Ltd.
name: Min Zhao, PhD
role: STUDY_DIRECTOR
References: