Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA) (HUA，SUA，MA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Asymptomatic Hyperuricemia
• Intervention / Treatment: Device: Manual acupuncture; Device: Sham acupuncture

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingling Yu, PhD; Phone Number: 86-13545862185; Email: 527679774@qq.com
• Study Contact Backup: Name: Shenghao Tu, PhD; Phone Number: 86-13971535353; Email: shtu@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Lingling Yu, PhD; Phone Number: 86-13545862185; Email: 527679774@qq.com
      • Contact: Shenghao Tu, PhD; Phone Number: 86-13971535353; Email: shtu@tjh.tjmu.edu.cn
      • Contact: Lingling Yu, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual acupuncture group; Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period.	Device: Manual 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.
Sham Comparator: Sham acupuncture group; 20 sessions of non-penetrating sham acupuncture will be performed at non-acupuncture points, which are located on the back and with different segments from the kidney organ area，over 8 weeks of treatment period.	Device: Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum uric acid (SUA)	Changes in the SUA level after 8 weeks of treatment.	Baseline and 8 weeks after randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with SUA ≤ 6.0 mg/dL	The proportion of participants with SUA ≤ 6.0 mg/dL after treatment.	4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Proportion of participants with SUA ≤ 7.0 mg/dL.	The proportion of participants with SUA ≤ 7.0 mg/dL after treatment.	4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
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	The proportion of participants with gout attacks after randomization	4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Changes in the body weight after treatment.	baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Abdominal circumference	Changes in abdominal circumference after treatment.	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)	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.
Traditional Chinese medicine (TCM) constitution	Changes in the Traditional Chinese medicine (TCM) constitution after treatment	baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Pittsburgh Sleep Quality Index (PSQI)	Changes in the PSQI after 4 weeks of treatment.	baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Beck Depression Inventory II (BDI- II)	Changes in the BDI- II after treatment.	baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Beck Anxiety Inventory (BAI)	Changes in the BAI after treatment	baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Adverse events (AEs)	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.	From the beginning of acupuncture , up to 24 hours after acupuncture.
The intensity of acupuncture de qi sensation.	The Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) after each manual or sham acupuncture treatment	Ten minutes after each manual or sham acupuncture treatment.

Collaborators and Investigators

• Sponsor: Shenghao Tu
• Collaborators: Wuhan Union Hospital, China; Hainan General Hospital; Beijing Hospital of Traditional Chinese Medicine; Yichang Central People's Hospital; Wuhan No.1 Hospital; The Second Hospital of Huangshi; Puyang Hospital of Traditional Chinese Medicine; Xianning Hospital of Traditional Chinese Medicine, China; Qianjiang Central Hospital, China
• Investigators: Principal Investigator: Shenghao Tu, Ph.D, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: MA; HUA; SUA; deqi
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: 2023HUATJ01-V1.1(20240206); ZY2021Z002 (Other Grant/Funding Number: TCM Scientific Research Project of Hubei Provincial Health Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD after de-identification can be shared on individual request to the principal investigator at shtu@tjh.tjmu.edu.cn
• IPD Sharing Time Frame: IPD and supporting information will be available after the publication of the primary outcomes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No