the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD

Diabetic Nephropathy Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681249
• Other study ID #: 17401970500-b
• Status: Completed
• Phase: Early Phase 1
• Start date: November 2, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 IV;

3. eGFR = 30 ml / min / 1.73 m2;

4. Age 18-75 years old, gender ðnicity are not limited;

5. glycated hemoglobin = 10%;

6. 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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy Type 2

Intervention

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

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24H urine total protein	t24-hour urine total protein quantitation in stage ? diabetes kidney disease patients	24 weeks