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

Primary Purpose

Non-proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Compound danshen dripping pills
Placebo
Sponsored by
Tasly Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-proliferative Diabetic Retinopathy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  • Dongfang Hospital, Beijing University of Chinese Medicine
  • Southwest Hospital, Third Military Medical University
  • The First Affiliated Hospital of Guangzhou University of TCM
  • The First Affiliated Hospital of Guangxi Medical University
  • Henan Institute of Ophthalmology
  • Hubei Provincial Hospital of TCM
  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
  • The First Hospital of Hunan University of Chinese Medicine
  • Jiangsu Province Hospital of TCM
  • Jiangxi Provincial People's Hospital
  • The Affiliated Hospital of Changchun University of Chinese Medicine
  • Shenyang He Eye Hospital
  • Yantai Yuhuangding Hospital
  • Shanghai General Hospital
  • Teaching Hospital of Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Compound danshen dripping pills

Placebo

Arm Description

Compound danshen dripping pills,20pills,tid. Duration: 24 weeks.

Placebo,20pills,tid. Duration: 24 weeks.

Outcomes

Primary Outcome Measures

The total effective rate of Fundus changes, the severity of diabetic retinopathy change from baseline at the end of week 24 compared to placebo

Secondary Outcome Measures

Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo
Corrected visual acuity change from baseline at the end of week 24 compared to placebo
The severity of macular edema change from baseline at the end of week 24 compared to placebo

Full Information

First Posted
March 2, 2015
Last Updated
March 20, 2017
Sponsor
Tasly Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02388984
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compound danshen dripping pills
Arm Type
Experimental
Arm Description
Compound danshen dripping pills,20pills,tid. Duration: 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo,20pills,tid. Duration: 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Compound danshen dripping pills
Other Intervention Name(s)
Dantonic®
Intervention Description
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo
Time Frame
24 weeks.
Title
Corrected visual acuity change from baseline at the end of week 24 compared to placebo
Time Frame
24 weeks.
Title
The severity of macular edema change from baseline at the end of week 24 compared to placebo
Time Frame
24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Zhao, PhD
Organizational Affiliation
Tasly Group, Co. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Bei Jing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Dongfang Hospital, Beijing University of Chinese Medicine
City
Bei Jing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Facility Name
Southwest Hospital, Third Military Medical University
City
Chong Qing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou University of TCM
City
Guang Zhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nan Ning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Henan Institute of Ophthalmology
City
Zheng Zhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Hubei Provincial Hospital of TCM
City
Wu Han
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
City
Wu Han
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
The First Hospital of Hunan University of Chinese Medicine
City
Chang Sha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Jiangsu Province Hospital of TCM
City
Nan Jing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nan Chang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
The Affiliated Hospital of Changchun University of Chinese Medicine
City
Chang Chun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Shenyang He Eye Hospital
City
Shen Yang
State/Province
Liaoning
ZIP/Postal Code
110141
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yan Tai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Shanghai General Hospital
City
Shang Hai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Teaching Hospital of Chengdu University of TCM
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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