Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)

NCT06824376 | Recruiting DMC

• 2 other identifiers: 2023HUATJ01-V1.1(20240206)ZY2021Z002
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asymptomatic Hyperuricemia

Keywords

MA; HUA; SUA; deqi

Outcome Measures

Primary Outcomes (1)

• Serum uric acid (SUA)

  Changes in the SUA level after 8 weeks of treatment.

  Baseline and 8 weeks after randomization.

Secondary Outcomes (4)

• 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.

• 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.

• 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.

Other Outcomes (9)

• Body weight

  baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.

• Abdominal circumference

  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)

  baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.

Study Arms (2)

Manual acupuncture group

EXPERIMENTAL

Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period.

Device: Manual acupuncture

Sham acupuncture group

SHAM COMPARATOR

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

Interventions

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.

Manual acupuncture group

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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• kg/m2 ≤ body mass index (BMI) ≤ 30.0 kg/m2.
• Can write informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

Study Officials

• Shenghao Tu, Ph.D

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenghao Tu, PhD

CONTACT

86-13971535353; shtu@tjh.tjmu.edu.cn

Lingling Yu, PhD

CONTACT

86-13545862185; 527679774@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 13, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available after the publication of the primary outcomes.

Locations

CN (1)