Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy
A Randomized, Double Blind, Multi-Center Study of Compound Danshen Dripping Pills in Patients With Diabetic Retinopathy (Syndrome Of Qi-Stagnation and Blood Stasis)
1 other identifier
interventional
480
1 country
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2013
Longer than P75 for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 21, 2017
March 1, 2017
4 years
March 2, 2015
March 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Compound danshen dripping pills
EXPERIMENTALCompound danshen dripping pills,20pills,tid. Duration: 24 weeks.
Placebo
PLACEBO COMPARATORPlacebo,20pills,tid. Duration: 24 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Dongfang Hospital, Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100078, China
Southwest Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Guangzhou University of TCM
Guangzhou, Guangdong, 510405, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Henan Institute of Ophthalmology
Zhengzhou, Henan, 450003, China
Hubei Provincial Hospital of TCM
Wuhan, Hubei, 430022, China
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410000, China
Jiangsu Province Hospital of TCM
Nanjing, Jiangsu, 210029, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, 130021, China
Shenyang He Eye Hospital
Shenyang, Liaoning, 110141, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610075, China
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Min Zhao, PhD
Tasly Group, Co. Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2015
First Posted
March 17, 2015
Study Start
May 1, 2013
Primary Completion
May 1, 2017
Study Completion
December 1, 2017
Last Updated
March 21, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share