Clinical Efficacy and Safety of Warm Acupuncture in the treatment of Type 2 Diabetic Kidney Disease: A protocol of a randomized controlled trial

Phase 1

• Conditions: Type 2 diabetic kidney disease (DKD) is one of the most common and harmful chronic complications in clinical practice, and there is no reliable and targeted treatment plan at present. As a classic complementary and alternative therapy, evidence have shown that warm acupuncture has advantages in the treatment of type 2 DKD. However, there is still a lack of high-quality and long-term follow-up randomized controlled trials (RCTs) of warm acupuncture in the treatment of type 2 DKD.; Warm acupuncture; Type 2 diabetic kidney disease; Randomized controlled trial; protocol

• Registration Number: TCTR20221104004
• Lead Sponsor: Hongbo Chen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1 Meet the diagnostic criteria of type 2 DKD
2 Age no less than 18 years old, and be not more than 70 years old, regardless of gender
3With the 24-hour urinary protein quantification was 0.5-3.5 g
4 With serum creatinine less than 265umol/L
5 Patients voluntarily participated in the trial and signed informed consent

Exclusion Criteria

(1) Nephropathy due to hypertension or other diseases;
(2) Complicated with severe complications and other serious organ dysfunction;
(3)Complicated with severe heart disease (NYHA class 3 or above, severe arrhythmia), abnormal liver function (alanine aminotransferase, aspartate aminotransferase no less than 1.5 times the upper limit of normal value), hematopoietic system diseases (moderate to severe anemia);
(4) Complicated with severe infection, diabetic ketoacidosis, hyperkalemia;
(5) Complicated with severe mental illness;
(6) Pregnant or lactating women;
(7) Patients with a history of allergy to one of the drugs used in the study;
(8) Subjects participating in clinical trials of other drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour urinary protein 8, 12, and 24 weeks urinalysis test

Secondary Outcome Measures

Name	Time	Method
Renal function 8, 12, and 24 weeks Renal function test