Efficacy and Safety Study of Manual Acupuncture (MA) on Serum Uric Acid (SUA) Outcomes in Patients With Asymptomatic Hyperuricemia (HUA): a Multi-center, Randomized, Sham-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Serum uric acid (SUA)
Study Overview
Brief Summary
Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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.
Arms & Interventions
Manual acupuncture group
Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period.
Intervention: Manual acupuncture (Device)
Sham acupuncture group
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.
Intervention: Sham acupuncture (Device)
Outcomes
Primary Outcomes
Serum uric acid (SUA)
Time Frame: Baseline and 8 weeks after randomization.
Changes in the SUA level after 8 weeks of treatment.
Secondary Outcomes
- Proportion of participants with SUA ≤ 6.0 mg/dL(4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.)
- Proportion of participants with SUA ≤ 7.0 mg/dL.(4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.)
- Dynamic changes in the SUA level after treatment.(Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.)
- The proportion of participants with gout attacks(4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.)
Investigators
Shenghao Tu
Professor
Tongji Hospital