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Completed

NCT Number: NCT03681249

the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

About this study

The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital of Integrated Traditional Chinese Medicine and Western Medicine, China.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Identify the diagnosis of type 2 diabetes;
  • It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV;
  • eGFR ≥ 30 ml / min / 1.73 m2;
  • Age 18-75 years old, gender &ethnicity are not limited;
  • glycated hemoglobin ≤ 10%;
  • Blood pressure is controlled below 130/80mmHg

Exclusion criteria

  • Combine other ACEI and ARB application indications other than hypertension;
  • Combine severe primary diseases related to heart, brain, liver and hematopoietic system;
  • Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month;
  • Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities;
  • Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents;
  • Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states;
  • pregnant or lactating women;
  • Patients who accepted other clinical trial studies on going ;
  • Patients who combined with serious diseases and dysfunctions in other organs.

Treatment and study plan

ShenqiDihuang Decoction

Drug

ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks

Other names: nseng, Astragalus, Rehmannia and other TCMs Decoction

ShenqiDihuang Decoction placebo

Drug

traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks

Other names: Ginseng, Astragalus, Rehmannia Decoction placebo

Primary outcomes

  1. 24H urine total protein

    Time frame: 24 weeks

    t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients

Sponsors and collaborators

Lead sponsor

Shanghai University of Traditional Chinese Medicine

Other

Collaborators

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Registry information

Official study title

Multicenter Clinical Study on the Treatment of Middle Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 24, 2018
Registry last updated
May 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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