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Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02388984
Recruitment Status : Unknown
Verified March 2017 by Tasly Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tasly Pharmaceuticals, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Non-proliferative Diabetic Retinopathy Drug: Compound danshen dripping pills Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2013
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Compound danshen dripping pills
Compound danshen dripping pills,20pills,tid. Duration: 24 weeks.
 Drug: Compound danshen dripping pills
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Other Name: Dantonic®
Placebo Comparator: Placebo
Placebo,20pills,tid. Duration: 24 weeks.
 Drug: Placebo
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: 24weeks ]

Secondary Outcome Measures :
  1. Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo [ Time Frame: 24 weeks. ]
  2. Corrected visual acuity change from baseline at the end of week 24 compared to placebo [ Time Frame: 24 weeks. ]
  3. The severity of macular edema change from baseline at the end of week 24 compared to placebo [ Time Frame: 24weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388984


Locations
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China, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Bei Jing, Beijing, China, 100053
Dongfang Hospital, Beijing University of Chinese Medicine
Bei Jing, Beijing, China, 100078
China, Chongqing
Southwest Hospital, Third Military Medical University
Chong Qing, Chongqing, China, 400038
China, Guangdong
The First Affiliated Hospital of Guangzhou University of TCM
Guang Zhou, Guangdong, China, 510405
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University
Nan Ning, Guangxi, China, 530021
China, Henan
Henan Institute of Ophthalmology
Zheng Zhou, Henan, China, 450003
China, Hubei
Hubei Provincial Hospital of TCM
Wu Han, Hubei, China, 430022
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wu Han, Hubei, China, 430022
China, Hunan
The First Hospital of Hunan University of Chinese Medicine
Chang Sha, Hunan, China, 410000
China, Jiangsu
Jiangsu Province Hospital of TCM
Nan Jing, Jiangsu, China, 210029
China, Jiangxi
Jiangxi Provincial People's Hospital
Nan Chang, Jiangxi, China, 330006
China, Jilin
The Affiliated Hospital of Changchun University of Chinese Medicine
Chang Chun, Jilin, China, 130021
China, Liaoning
Shenyang He Eye Hospital
Shen Yang, Liaoning, China, 110141
China, Shandong
Yantai Yuhuangding Hospital
Yan Tai, Shandong, China, 264000
China, Shanghai
Shanghai General Hospital
Shang Hai, Shanghai, China, 200080
China, Sichuan
Teaching Hospital of Chengdu University of TCM
Cheng Du, Sichuan, China, 610075
Sponsors and Collaborators
Tasly Pharmaceuticals, Inc.
Investigators
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Study Director: Min Zhao, PhD Tasly Group, Co. Ltd.
More Information
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Responsible Party: Tasly Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02388984    
Other Study ID Numbers: TCM9001-04
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases