Asymptomatic Hyperuricemia
Conditions
Keywords
MA, HUA, SUA, deqi
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.
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.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Xianning Hospital of Traditional Chinese Medicine, China
Beijing Hospital of Traditional Chinese Medicine
Qianjiang Central Hospital, China
Hainan General Hospital
Yichang Central People's Hospital
Wuhan No.1 Hospital
The Second Hospital of Huangshi
Puyang Hospital of Traditional Chinese Medicine
Shenghao Tu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum uric acid (SUA) | Baseline and 8 weeks after randomization. | Changes in the SUA level after 8 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with SUA ≤ 6.0 mg/dL | 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | The proportion of participants with SUA ≤ 6.0 mg/dL after treatment. |
| Proportion of participants with SUA ≤ 7.0 mg/dL. | 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | The proportion of participants with SUA ≤ 7.0 mg/dL after treatment. |
| Dynamic changes in the SUA level after treatment. | Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | — |
| The proportion of participants with gout attacks | 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | The proportion of participants with gout attacks after randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory II (BDI- II) | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | Changes in the BDI- II after treatment. |
| Beck Anxiety Inventory (BAI) | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | Changes in the BAI after treatment |
| Body weight | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | Changes in the body weight after treatment. |
| The intensity of acupuncture de qi sensation. | Ten minutes after each manual or sham acupuncture treatment. | The Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) after each manual or sham acupuncture treatment |
| Adverse events (AEs) | From the beginning of acupuncture , up to 24 hours after acupuncture. | AEs in which a causal relationship to the manual acupuncture or sham acupuncture cannot be ruled out will be considered an adverse reactions from the acupuncture. AEs related to acupuncture may include abnormal pain, bleeding, congestion, broken needles, bent needles, and dizziness. |
| Abdominal circumference | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | Changes in abdominal circumference after treatment. |
| NEO Personality Inventory-Short Form (NEO-FFI) | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | NEO Personality Inventory-Short Form (NEO-FFI) |
| Traditional Chinese medicine (TCM) constitution | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | Changes in the Traditional Chinese medicine (TCM) constitution after treatment |
| Pittsburgh Sleep Quality Index (PSQI) | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. | Changes in the PSQI after 4 weeks of treatment. |
Countries
China
Contacts
Primary ContactShenghao Tu, PhD
Backup ContactLingling Yu, PhD
Outcome results
None listed