Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy
NCT ID: NCT02388984
Last Updated: 2017-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
480 participants
INTERVENTIONAL
2013-05-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Compound danshen dripping pills
Compound danshen dripping pills,20pills,tid. Duration: 24 weeks.
Compound danshen dripping pills
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Placebo
Placebo,20pills,tid. Duration: 24 weeks.
Placebo
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Interventions
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Compound danshen dripping pills
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Placebo
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. aged 30-70 years
3. voluntary signs the informed consent
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
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).
30 Years
70 Years
ALL
No
Sponsors
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Tasly Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Min Zhao, PhD
Role: STUDY_DIRECTOR
Tasly Group, Co. Ltd.
Locations
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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
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
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, China
Shenyang He Eye Hospital
Shenyang, Liaoning, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, China
Countries
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Other Identifiers
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TCM9001-04
Identifier Type: -
Identifier Source: org_study_id
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