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NCT Number: NCT06824376

Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)

Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.

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Key information

Conditions

Asymptomatic Hyperuricemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location status: Recruiting

Location contact

Lingling Yu, Ph.D

SUB_INVESTIGATOR

Lingling Yu, PhD

CONTACT

[email protected]

86-13545862185

Shenghao Tu, PhD

CONTACT

[email protected]

86-13971535353

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual acupuncture

Device

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.

Sham acupuncture

Device

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 outcomes

  1. Serum uric acid (SUA)

    Time frame: Baseline and 8 weeks after randomization.

    Changes in the SUA level after 8 weeks of treatment.

Secondary outcomes

  1. 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.

    The proportion of participants with SUA ≤ 6.0 mg/dL after treatment.

  2. 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.

    The proportion of participants with SUA ≤ 7.0 mg/dL after treatment.

  3. Dynamic changes in the SUA level after treatment.

    Time frame: Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.

  4. 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.

    The proportion of participants with gout attacks after randomization

Other outcomes

  1. Body weight

    Time frame: 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.

  2. Abdominal circumference

    Time frame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.

    Changes in abdominal circumference after treatment.

  3. NEO Personality Inventory-Short Form (NEO-FFI)

    Time frame: 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)

  4. Traditional Chinese medicine (TCM) constitution

    Time frame: 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

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  6. Beck Depression Inventory II (BDI- II)

    Time frame: 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.

  7. Beck Anxiety Inventory (BAI)

    Time frame: baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.

    Changes in the BAI after treatment

  8. Adverse events (AEs)

    Time frame: 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.

  9. The intensity of acupuncture de qi sensation.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lingling Yu, PhD

CONTACT

[email protected]

86-13545862185

Shenghao Tu, PhD

CONTACT

[email protected]

86-13971535353

Sponsors and collaborators

Lead sponsor

Shenghao Tu

Other

Collaborators

  • Beijing Hospital of Traditional Chinese Medicine
  • Hainan General Hospital
  • Puyang Hospital of Traditional Chinese Medicine
  • Qianjiang Central Hospital, China
  • The Second Hospital of Huangshi
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan No.1 Hospital
  • Xianning Hospital of Traditional Chinese Medicine, China
  • Yichang Central People's Hospital

Registry information

Official study 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

Acronym: HUA，SUA，MA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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