Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy

NCT ID: NCT05418465

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2022-12-31

Brief Summary

This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic nephropathy.

Detailed Description

The incidence rate of chronic kidney disease is 10.8% in China. The incidence rate of diabetic nephropathy has increased year by year, and now it has become the first cause of uremia. Therefore, the treatment of diabetic nephropathy can delay the progression of renal function and is of great value and significance in reducing uremia. Huangqi Guizhi Wuwu decoction is a traditional Chinese medicine decoction. Previous studies have shown that it is effective in the treatment of diabetic nephropathy. In this study, there were 2 hospitals participating in. We planned to enroll 100 participants, who will be divided into the Huangqi Guizhi Wuwu decoction group (experimental group) and the Dapagliflozin group (control group). All participants will take medication for 12 weeks, and investigators will follow up participates at weeks 0, 2,4, 6, 8,12.

Conditions

Diabetic Nephropathies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Huangqi Guizhi Wuwu decoction group

Huangqi Guizhi Wuwu decoction

Group Type: EXPERIMENTAL

Huangqi Guizhi Wuwu decoction

Intervention Type: DRUG

Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.

Dapagliflozin group

Dapagliflozin

Group Type: ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin, 10mg at a time, once a day. Oral administration.

Interventions

Huangqi Guizhi Wuwu decoction

Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.

Intervention Type: DRUG

Dapagliflozin

Dapagliflozin, 10mg at a time, once a day. Oral administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed as diabetic nephropathy

2. TCM syndrome differentiation is Qi deficiency and blood stasis type

3. Male or female, 18≤age≤75 4.25mL/（min.1.73m2）≤ eGFR<90mL/（min.1.73m2） 5.24-hour urine protein ration ≤3.5g/24h

6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document

Exclusion Criteria

1. Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period

2. Urinary tract infection (leukocytes in urinary sediment > 5 / HP)

3. Serum potassium > 5.5 mmol/L

4. Serum albumin < 30g/L

5. Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period

6. Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis)

7. Participating in another clinical trial

8. Investigators do not think it suitable for a participant to join this study

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

Sponsors

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ming Fang

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Dalian medical university

Dalian, Liaoning, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Dapeng Wang, MD

Role: primary

bobowdp@163.com

+86-18098875653

Other Identifiers

PJ-KS-KY-2021-228(X2)

Identifier Type: -

Identifier Source: org_study_id