Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Manual acupuncture
  After sterilisation, the sharp needles will be inserted into the deep tissue layers of acupoints. Acupuncturists will tried to elicit acupuncture de-qi sensation by the manual manipulation of needles. Within a 30-minute period, manual manipulation for each acupoint will last at least 10 seconds and wil repeated four times with intervals of 10-minute.
• Устройство Sham acupuncture
  After sterilisation, Streitberger placebo needles with blunt tip will be used. It can be fixed on the surface of the sham points without piercing the skin. Within a 30-minute period, each point will undergo a simulated twisting motion of the needle for at least 10 seconds, and this will be repeated four times at 10-minute intervals.

Первичные конечные точки

• Serum uric acid (SUA) [Срок оценки: Baseline and 8 weeks after randomization.]

Вторичные конечные точки (4)

• Proportion of participants with SUA ≤ 6.0 mg/dL [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.]
• The proportion of participants with gout attacks [Срок оценки: 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji — Ухань

Идентификаторы

NCT: NCT06824376 · 2023HUATJ01-V1.1(20240206) · ZY2021Z002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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