Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA) (HUA，SUA，MA)

Shenghao Tu

Status: Enrolling

Conditions: Asymptomatic Hyperuricemia

Treatments: Device: Sham acupuncture; Device: Manual acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06824376

ZY2021Z002 (Other Grant/Funding Number)

2023HUATJ01-V1.1(20240206)

Details and patient eligibility

About

Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.

Full description

This is a multicenter randomized, single-blind, sham-controlled trial. A total of 260 eligible patients with asymptomatic hyperuricemia will be randomly assigned in a 1:1 ratio to manual acupuncture group or sham acupuncture group.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With serum uric acid (SUA) level >7 mg/dL after 1 month of a low-purine diet.
• No history of gouty arthritis.
• Has not received uric acid-lowering drug treatment or stopped uric acid- lowering drug treatment ≥ 12 weeks.
• 18.5kg/m2 ≤ body mass index (BMI) ≤ 30.0 kg/m2.
• Can write informed consent.

Exclusion criteria

• Patients with poorly controlled hypertension: systolic blood pressure (SBP) ≥ 160mmHg, diastolic blood pressure (DBP) ≥ 100 mmHg.
• Patients with poorly controlled diabetes (hemoglobin A1c ≥ 8.4%).
• Patients with severe liver and kidney damage: chronic kidney disease (CKD) ≥ stage 2 or a serum creatinine, urea, alanine, or aspartate aminotransferase level more than twice of the upper limit.
• Patients with blood system diseases, such as acute and chronic leukemia, polycythemia, multiple myeloma, hemolytic anemia, lymphoma, or undergoing chemotherapy for multiple solid tumors.
• Patients with stroke, coronary heart disease, or severe neuropsychological diseases.
• Patients who are pregnant.
• Illiterate or unwilling to accept acupuncture treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Manual acupuncture group

Experimental group

Description:

Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period.

Treatment:

Device: Manual acupuncture

Sham acupuncture group

Sham Comparator group

Description:

20 sessions of non-penetrating sham acupuncture will be performed at non-acupuncture points, which are located on the back and with different segments from the kidney organ area，over 8 weeks of treatment period.

Treatment:

Device: Sham acupuncture