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

Last updated: March 20, 2017
Sponsor: Tasly Pharmaceuticals, Inc.
Overall Status: Trial Status Unknown

Phase

3

Condition

Retina

Diabetic Vitreous Hemorrhage

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT02388984
TCM9001-04
  • Ages 30-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndromedifferentiation 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 theinclusion criteria, please record respectively, and select one eye for efficacy evaluationwith reference to the following principles: When the two eyes of fundus conditions in different clinical stage, choose the more seriousone. When the two eyes of fundus conditions in the same clinical stage, choose the eye easierfor clinical operation.

Exclusion

Exclusion Criteria:

  1. HbAlc>8%, sustained hyperglycemia.

  2. The patients who have been received the therapy of Retina laser photocoagulation ordiagnosed 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 thelimit 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 becomepregnant. 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 Design

Total Participants: 480
Study Start date:
May 01, 2013
Estimated Completion Date:
December 31, 2017

Study 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.

Connect with a study center

  • Dongfang Hospital, Beijing University of Chinese Medicine

    Bei Jing, Beijing 100078
    China

    Site Not Available

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    Bei Jing, Beijing 100053
    China

    Site Not Available

  • Southwest Hospital, Third Military Medical University

    Chong Qing, Chongqing 400038
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou University of TCM

    Guang Zhou, Guangdong 510405
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nan Ning, Guangxi 530021
    China

    Site Not Available

  • Henan Institute of Ophthalmology

    Zheng Zhou, Henan 450003
    China

    Site Not Available

  • Hubei Provincial Hospital of TCM

    Wu Han, Hubei 430022
    China

    Site Not Available

  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

    Wu Han, Hubei 430022
    China

    Site Not Available

  • The First Hospital of Hunan University of Chinese Medicine

    Chang Sha, Hunan 410000
    China

    Site Not Available

  • Jiangsu Province Hospital of TCM

    Nan Jing, Jiangsu 210029
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nan Chang, Jiangxi 330006
    China

    Site Not Available

  • The Affiliated Hospital of Changchun University of Chinese Medicine

    Chang Chun, Jilin 130021
    China

    Site Not Available

  • Shenyang He Eye Hospital

    Shen Yang, Liaoning 110141
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yan Tai, Shandong 264000
    China

    Site Not Available

  • Shanghai General Hospital

    Shang Hai, Shanghai 200080
    China

    Site Not Available

  • Teaching Hospital of Chengdu University of TCM

    Cheng Du, Sichuan 610075
    China

    Site Not Available

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