RecruitingNot ApplicableNCT06824376

Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)

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


Sponsor

Shenghao Tu

Enrollment

260 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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.
  • 5kg/m2 ≤ body mass index (BMI) ≤ 30.0 kg/m2.
  • Can write informed consent.

Exclusion Criteria7

  • 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.

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Interventions

DEVICEManual 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.

DEVICESham 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.


Locations(1)

Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

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NCT06824376