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)

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).

Study Overview

• Status: Unknown
• Conditions: Non-proliferative Diabetic Retinopathy
• Intervention / Treatment: Drug: Compound danshen dripping pills; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Bei Jing, Beijing, China, 100053
      • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    • Bei Jing, Beijing, China, 100078
      • Dongfang Hospital, Beijing University of Chinese Medicine
  • Chongqing
    • Chong Qing, Chongqing, China, 400038
      • Southwest Hospital, Third Military Medical University
  • Guangdong
    • Guang Zhou, Guangdong, China, 510405
      • The First Affiliated Hospital of Guangzhou University of TCM
  • Guangxi
    • Nan Ning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Henan
    • Zheng Zhou, Henan, China, 450003
      • Henan Institute of Ophthalmology
  • Hubei
    • Wu Han, Hubei, China, 430022
      • Hubei Provincial Hospital of TCM
    • Wu Han, Hubei, China, 430022
      • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
  • Hunan
    • Chang Sha, Hunan, China, 410000
      • The First Hospital of Hunan University of Chinese Medicine
  • Jiangsu
    • Nan Jing, Jiangsu, China, 210029
      • Jiangsu Province Hospital of TCM
  • Jiangxi
    • Nan Chang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Chang Chun, Jilin, China, 130021
      • The Affiliated Hospital of Changchun University of Chinese medicine
  • Liaoning
    • Shen Yang, Liaoning, China, 110141
      • Shenyang He Eye Hospital
  • Shandong
    • Yan Tai, Shandong, China, 264000
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shang Hai, Shanghai, China, 200080
      • Shanghai General Hospital
  • Sichuan
    • Cheng Du, Sichuan, China, 610075
      • Teaching Hospital of Chengdu University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tasly Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: TCM9001-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No