Asymptomatic HyperuricemiaHUA，SUA，MANCT06824376
Manual Acupuncture (MA) for Asymptomatic Hyperuricemia (HUA)
A study testing Manual acupuncture in people with Asymptomatic Hyperuricemia, run by Shenghao Tu at 1 site in China.
Trial summary
Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asymptomatic Hyperuricemia
- What is being tested?
- Manual acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shenghao Tu, PhD, 86-13971535353, shtu@tjh.tjmu.edu.cn
Lingling Yu, PhD, 86-13545862185, 527679774@qq.com
About this study
Official 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
Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.
Read the 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.
- Conditions
- Asymptomatic Hyperuricemia
- Being tested
- Manual acupuncture, Sham acupuncture
- Keywords
- MA, HUA, SUA, deqi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual acupunctureDevice
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 acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual acupuncture group | Experimental | Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period. Receives: 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. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid (SUA)
Changes in the SUA level after 8 weeks of treatment.
Measured: Baseline and 8 weeks after randomization.
Secondary outcomes (4)
Proportion of participants with SUA ≤ 6.0 mg/dL
The proportion of participants with SUA ≤ 6.0 mg/dL after treatment.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start25 Mar 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenghao Tu
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor-investigator, Shenghao Tu, Tongji Hospital
- Investigators
- Shenghao Tu, Ph.D, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824376
- Sponsor's protocol ID
- 2023HUATJ01-V1.1(20240206)
- Other IDs
- ZY2021Z002
- Acronym
- HUA，SUA，MA
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD after de-identification can be shared on individual request to the principal investigator at shtu@tjh.tjmu.edu.cn
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06824376
- Acronym / sponsor ID
- HUA，SUA，MA / 2023HUATJ01-V1.1(20240206)
- Conditions
- Asymptomatic Hyperuricemia
- Keywords
- MA, HUA, SUA, deqi
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Shenghao TuUniversity, hospital or other
- Collaborators
- 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
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual acupuncture group | Experimental | Device: Manual acupunctureAcupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period. |
| Sham acupuncture group | Sham comparator | Device: Sham acupuncture20 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual acupunctureAfter 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. | Device | Manual acupuncture group |
| Sham acupunctureAfter 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. | Device | Sham acupuncture group |
Primary outcome
Serum uric acid (SUA)
Time frame: Baseline and 8 weeks after randomization.
Changes in the SUA level after 8 weeks of treatment.
4 secondary outcomes
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.
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.
Dynamic changes in the SUA level after treatment.
Time frame: Baseline, 4 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes. IPD after de-identification can be shared on individual request to the principal investigator at shtu@tjh.tjmu.edu.cn
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shenghao Tu, Ph.D principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual acupuncture in people with Asymptomatic Hyperuricemia, run by Shenghao Tu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shenghao Tu, PhD (86-13971535353, shtu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum uric acid (SUA) (time frame: Baseline and 8 weeks after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.