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

Sponsor
Tasly Pharmaceuticals, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02388984
Collaborator
(none)
480
Enrollment
16
Locations
2
Arms
55
Duration (Months)
30
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
Anticipated 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 1, 2013
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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.

    Outcome Measures

    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 [24weeks]

    Secondary Outcome Measures

    1. Symptoms scores of TCM change from baseline at the end of week 24 compared to placebo [24 weeks.]

    2. Corrected visual acuity change from baseline at the end of week 24 compared to placebo [24 weeks.]

    3. The severity of macular edema change from baseline at the end of week 24 compared to placebo [24weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Guang'anmen Hospital of China Academy of Chinese Medical Sciences Bei Jing Beijing China 100053
    2 Dongfang Hospital, Beijing University of Chinese Medicine Bei Jing Beijing China 100078
    3 Southwest Hospital, Third Military Medical University Chong Qing Chongqing China 400038
    4 The First Affiliated Hospital of Guangzhou University of TCM Guang Zhou Guangdong China 510405
    5 The First Affiliated Hospital of Guangxi Medical University Nan Ning Guangxi China 530021
    6 Henan Institute of Ophthalmology Zheng Zhou Henan China 450003
    7 Hubei Provincial Hospital of TCM Wu Han Hubei China 430022
    8 Union Hospital, Tongji Medical College,Huazhong University of Science and Technology Wu Han Hubei China 430022
    9 The First Hospital of Hunan University of Chinese Medicine Chang Sha Hunan China 410000
    10 Jiangsu Province Hospital of TCM Nan Jing Jiangsu China 210029
    11 Jiangxi Provincial People's Hospital Nan Chang Jiangxi China 330006
    12 The Affiliated Hospital of Changchun University of Chinese Medicine Chang Chun Jilin China 130021
    13 Shenyang He Eye Hospital Shen Yang Liaoning China 110141
    14 Yantai Yuhuangding Hospital Yan Tai Shandong China 264000
    15 Shanghai General Hospital Shang Hai Shanghai China 200080
    16 Teaching Hospital of Chengdu University of TCM Cheng Du Sichuan China 610075

    Sponsors and Collaborators

    • Tasly Pharmaceuticals, Inc.

    Investigators

    • Study Director: Min Zhao, PhD, Tasly Group, Co. Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tasly Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02388984
    Other Study ID Numbers:
    • TCM9001-04
    First Posted:
    Mar 17, 2015
    Last Update Posted:
    Mar 21, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy

    Study Results

    No Results Posted as of Mar 21, 2017