Menu
Recruiting NCT06824376

Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)

No phase Interventional Asymptomatic Hyperuricemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual acupuncture, Sham acupuncture.
Who it may be relevant to
Registry conditions: Asymptomatic Hyperuricemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • Serum uric acid (SUA) [Time frame: Baseline and 8 weeks after randomization.]
Secondary outcome measures (4)
  • Proportion of participants with SUA ≤ 6.0 mg/dL [Time frame: 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. [Time frame: 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. [Time frame: Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.]
  • The proportion of participants with gout attacks [Time frame: 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji — Wuhan

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗