Clinical trial NCT06824376: Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asymptomatic Hyperuricemia
Keywords: MA
HUA
SUA
deqi
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Union Hospital, China
name: Xianning Hospital of Traditional Chinese Medicine, China
name: Beijing Hospital of Traditional Chinese Medicine
name: Qianjiang Central Hospital, China
name: Hainan General Hospital
name: Yichang Central People's Hospital
name: Wuhan No.1 Hospital
name: The Second Hospital of Huangshi
name: Puyang Hospital of Traditional Chinese Medicine
First posted: 2025-02-13
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Serum uric acid (SUA)
timeFrame: Baseline and 8 weeks after randomization.
Secondary outcomes:
measure: Proportion of participants with SUA ≤ 6.0 mg/dL
timeFrame: 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Proportion of participants with SUA ≤ 7.0 mg/dL.
timeFrame: 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Dynamic changes in the SUA level after treatment.
timeFrame: Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: The proportion of participants with gout attacks
timeFrame: 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Other outcomes:
measure: Body weight
timeFrame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Abdominal circumference
timeFrame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: NEO Personality Inventory-Short Form (NEO-FFI)
timeFrame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Traditional Chinese medicine (TCM) constitution
timeFrame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Beck Depression Inventory II (BDI- II)
timeFrame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
measure: Adverse events (AEs)
timeFrame: From the beginning of acupuncture , up to 24 hours after acupuncture.
measure: The intensity of acupuncture de qi sensation.
timeFrame: Ten minutes after each manual or sham acupuncture treatment.
Locations:
city: Wuhan
country: China
facility: Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Shenghao Tu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: