Using manual acupuncture to lower uric acid levels in patients without symptoms

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

This study is testing if manual acupuncture can help lower uric acid levels in people who have high uric acid but no symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06824376 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, single-blind, sham-controlled trial aims to evaluate the effectiveness of manual acupuncture in reducing serum uric acid levels in patients diagnosed with asymptomatic hyperuricemia. A total of 260 eligible participants will be randomly assigned to receive either manual acupuncture or sham acupuncture. The study will assess the impact of these interventions on uric acid levels after participants have followed a low-purine diet for one month. The trial seeks to provide insights into alternative treatment options for managing hyperuricemia.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with asymptomatic hyperuricemia and elevated serum uric acid levels who have not received uric acid-lowering treatments recently.

Not a fit: Patients with a history of gouty arthritis, poorly controlled hypertension, diabetes, or severe liver and kidney damage may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a non-pharmacological approach to managing serum uric acid levels, potentially reducing the risk of developing gout.

How similar studies have performed: While acupuncture has been explored in various contexts, this specific approach to treating asymptomatic hyperuricemia is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Wuhan, Hubei

• Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Shenghao Tu, Ph.D — Tongji Hospital
• Study coordinator: Shenghao Tu, PhD

Conditions: Asymptomatic Hyperuricemia, MA, HUA, SUA, deqi