An interventional study of Manual acupuncture and Sham acupuncture in Asymptomatic Hyperuricemia, sponsored by Shenghao Tu. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Shenghao Tu · Not applicable, Interventional, and Treatment
Assess the effectiveness of manual acupuncture in modulating serum uric acid levels among patients diagnosed with asymptomatic hyperuricemia.
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.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's planned enrollment of 260 is above the median of 68 across 193 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →This is the only study on the registry with Shenghao Tu as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period.
Device: Manual acupuncture
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, 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.
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.
Serum uric acid (SUA)
Changes in the SUA level after 8 weeks of treatment.
Time frame: Baseline and 8 weeks after randomization.
Proportion of participants with SUA ≤ 6.0 mg/dL
The proportion of participants with SUA ≤ 6.0 mg/dL after treatment.
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.
The proportion of participants with SUA ≤ 7.0 mg/dL after treatment.
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
The proportion of participants with gout attacks after randomization
Time frame: 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization.
Body weight
Changes in the body weight after treatment.
Time frame: 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.
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)
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.
Traditional Chinese medicine (TCM) constitution
Changes in the Traditional Chinese medicine (TCM) constitution after treatment
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Ten minutes after each manual or sham acupuncture treatment.
Plan to share: Yes — IPD after de-identification can be shared on individual request to the principal investigator at shtu@tjh.tjmu.edu.cn
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD and supporting information will be available after the publication of the primary outcomes.
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Oct 2026, 19 months after the start.
Of 26 interventional studies with no phase under Hyperuricemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 34. This study's planned 19 months is above that.
How these figures are worked out, and which studies are left out of them.
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