the Integrated Traditional Chinese and Western Medicine Treat Early Stage DKD

NCT ID: NCT03681704

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-08
• Study Completion Date: 2021-12-31

Brief Summary

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

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.

Conditions

Diabetic Nephropathy Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HuangQi Decoction

HuangQi Decoction 150ml by mouth ,twice a day for 24 weeks

Group Type: EXPERIMENTAL

HuangQi Decoction

Intervention Type: DRUG

HuangQi Decoction 150ml twice a day for 24 weeks

HuangQi Decoction placebo

HuangQi Decoction placebo 150ml by mouth, twice a day for 24 weeks

Group Type: PLACEBO_COMPARATOR

HuangQi Decoction placebo

Intervention Type: DRUG

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

Interventions

HuangQi Decoction

HuangQi Decoction 150ml twice a day for 24 weeks

Intervention Type: DRUG

HuangQi Decoction placebo

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

Intervention Type: DRUG

Other Intervention Names

Astragalus and other TCMs Decoction; Astragalus Decoction placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yueyi Deng, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai University of Traditional Chinese Medicine

Locations

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

17401970500-a

Identifier Type: -

Identifier Source: org_study_id