the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD

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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Nephropathy Type 2
• Intervention / Treatment: Drug: HuangQi Decoction; Drug: HuangQi Decoction placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Identify the diagnosis of type 2 diabetes;
2. It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD III;
3. Age 18-75 years old, gender ＆ethnicity are not limited;
4. glycated hemoglobin ≤ 10%;
5. Blood pressure is controlled below 130/80mmHg

Exclusion Criteria:

1. Combine other ACEI and ARB application indications other than hypertension;
2. Combine severe primary diseases related to heart, brain, liver and hematopoietic system;
3. Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month;
4. Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities;
5. 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;
6. Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states;
7. pregnant or lactating women;
8. Patients who accepted other clinical trial studies on going ;
9. Patients who combined with serious diseases and dysfunctions in other organs.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HuangQi Decoction; HuangQi Decoction 150ml by mouth ,twice a day for 24 weeks	Drug: HuangQi Decoction; HuangQi Decoction 150ml twice a day for 24 weeks; Other Names: Astragalus and other TCMs Decoction
Placebo Comparator: HuangQi Decoction placebo; HuangQi Decoction placebo 150ml by mouth, twice a day for 24 weeks	Drug: HuangQi Decoction placebo; traditional Chinese medicine placebo mimic HuangQi Decoction 150ml twice a day for 24 weeks; Other Names: Astragalus Decoction placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR	the Urinary albumin/ creatinine ratios in stage Ⅲ diabetes kidney disease patients	24 weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Investigators: Principal Investigator: Yueyi Deng, PhD, Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Diabetic Kidney Disease，Traditional Chinese medicine
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Diabetic Nephropathies
• Other Study ID Numbers: 17401970500-a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No