Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)

NCT ID: NCT06824376

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asymptomatic Hyperuricemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Manual acupuncture group

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

Group Type EXPERIMENTAL

Manual acupuncture

Intervention Type 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 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.

Group Type SHAM_COMPARATOR

Sham acupuncture

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Xianning Hospital of Traditional Chinese Medicine, China

UNKNOWN

Sponsor Role collaborator

Beijing Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Qianjiang Central Hospital, China

UNKNOWN

Sponsor Role collaborator

Hainan General Hospital

OTHER

Sponsor Role collaborator

Yichang Central People's Hospital

OTHER

Sponsor Role collaborator

Wuhan No.1 Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Huangshi

UNKNOWN

Sponsor Role collaborator

Puyang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Shenghao Tu

OTHER

Sponsor Role lead

Responsible Party

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Shenghao Tu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shenghao Tu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shenghao Tu, PhD

Role: CONTACT

86-13971535353

Lingling Yu, PhD

Role: CONTACT

86-13545862185

Facility Contacts

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Shenghao Tu, PhD

Role: primary

86-13971535353

Lingling Yu, PhD

Role: backup

86-13545862185

Other Identifiers

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ZY2021Z002

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023HUATJ01-V1.1(20240206)

Identifier Type: -

Identifier Source: org_study_id

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