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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Serum uric acid (SUA)
研究概览
简要总结
Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Manual acupuncture group
Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period.
干预措施: 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.
干预措施: Sham acupuncture (Device)
结局指标
主要结局
Serum uric acid (SUA)
时间窗: Baseline and 8 weeks after randomization.
Changes in the SUA level after 8 weeks of treatment.
次要结局
- 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.)
研究者
Shenghao Tu
Professor
Tongji Hospital