Evaluating acupuncture for treating high uric acid levels without symptoms

Evaluating the Efficacy of Acupuncture for Patients With Asymptomatic Hyperuricemia (HUA): A Multicenter Randomized Controlled Clinical Trial

This study is testing if real acupuncture can help lower high uric acid levels in people who don't have any symptoms, compared to a fake acupuncture treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05406830 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of manual acupuncture in patients with asymptomatic hyperuricemia, a condition characterized by elevated serum uric acid levels. It is a multicenter, randomized, sham-controlled trial involving 180 participants who will be divided into two groups: one receiving actual acupuncture and the other receiving sham acupuncture. Participants will undergo 16 sessions of treatment over eight weeks, with primary outcomes focused on changes in serum uric acid levels measured at various intervals. The study also aims to assess secondary outcomes such as the incidence of acute gouty arthritis and changes in body weight and BMI.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with asymptomatic hyperuricemia, with fasting blood uric acid levels between 7-11.0 mg/dL and a BMI between 18.5 and 30.0.

Not a fit: Patients with a history of gouty arthritis or those currently using medications that affect uric acid metabolism will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new non-pharmacological treatment option for managing high uric acid levels, potentially reducing the risk of developing gout and other related conditions.

How similar studies have performed: While acupuncture has been used for various conditions, the specific efficacy for asymptomatic hyperuricemia remains uncertain, making this approach relatively novel.

Eligibility criteria

Inclusion Criteria:

* Diagnosed as hyperuricemia; and
* Fasting blood uric acid level ≥ 7-11.0 mg/dL after 1 month of low-purine diet; and
* Without history of gouty arthritis; and
* Without drug treatment for hyperuricemia or stop uric acid-lowering drug treatment ≥12 weeks; and
* 18.5kg/m2≤BMI≤30.0kg/ m2; and
* Able to signing a informed consent.

Exclusion Criteria:

* Those who are using or have used one of the following drugs for the treatment of hyperuricemia 12 weeks before eligibility evaluation, such as: allopurinol, benzbromarone, probesulfan, bugelone, toppirosteine, Busotan; and
* Patients are using or used other drugs that affect uric acid metabolism in the past 12 weeks, such as: thiazide diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, compound reserpine, pyrazinamide, nitrates fendipine, propranolol, and benzbromarone; and
* Patients have history of gouty arthritis; and
* Combined with secondary hyperurmicema, such as bone marrow and lymphoproliferative diseases, tumor radiotherapy and chemotherapy, liver cirrhosis and drug-induced hyperurmicema; and
* Combined with one of the following comorbidities: hypertension, diabetes, stroke, coronary heart disease, severe liver and kidney damage (≥CKD stage 2, or high creatinine, urea, glutamate, glutamate ≥ 2 times of the limit of clinical normal values); and
* Combined with severe neuropsychological diseases, such as severe anxiety, depression, and intellectual disability; and
* Pregnant women; and
* Unwilling to accept acupuncture treatment; and
* Illiterate, or patients unable to sign informed consent; and
* The completion rate of baseline screening data is ≤80%.

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, PhD — Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan,430030, China
• Study coordinator: Lingling Yu, PhD

Conditions: Asymptomatic Hyperuricemia, Manual Acupuncture, Serum Uric Acid, Efficacy, Safety