An interventional study of verum acupuncture and health education in Asymptomatic Hyperuricemia, sponsored by Lingling Yu (103250). Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Lingling Yu (103250) · Not applicable, Interventional, and Treatment
hyperuricemia (HUA) is an important risk factor for various chronic diseases, such as gout, and the current treatment programs for HUA are not ideal. It is urgent to find new methods to prevent and treat HUA and to carry out early clinical intervention. Acupuncture is commonly used for the treatment of HUA, while the evidence for its efficacy is still uncertain. This clinical trial aimed to evaluate the efficacy and safety of manual acupuncture for asymptomatic HUA.
This is a multicentre, stratified, randomized, sham-controlled clinical trial. 180 eligible participants will be randomly allocated into verum acupuncture group or sham acupuncture group, in a 1:1 ratio. The verum acupuncture group will receive 16 sessions of manual acupuncture treatments over an eight-week period, while the sham acupuncture group will receive sham acupuncture treatments with non-penetrating needling. Health education will be provided to participants in the two groups. The primary outcomes will be the changes in the mean levels of serum uric acid 8 weeks after randomization. The secondary outcomes will be the changes in the mean levels of serum uric acid 4, 12, 16, and 20 weeks after randomization. Other secondary outcomes included effective rates, the proportion of patients with acute gouty arthritis, changes in body weight and BMI, safety evaluation and deqi evaluation. The central randomization and data collection will be conducted by an electronic data management system.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's planned enrollment of 180 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 Lingling Yu (103250) 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.
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.
Participants will be treated by real manual acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.
Device: verum acupuncture · Behavioral: health education
Participants will be treated by non-penetrating sham acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.
Behavioral: health education · Device: sham acupuncture
The special type of acupuncture needles will be inserted into the skin of standard acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.
According to the Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia related Diseases in China and the 2012 Guidelines of the American College of Rheumatology, health education should be given as basic prevention. These include weight control, regular exercise, limiting alcohol and high-purine and high-fructose diets, encouraging dairy and fresh vegetables and drinking moderate amounts of water, and not recommending or limiting soy products.
We will use a non-insertive sham control. Sham points are located at 5 cun lateral to the seventh, eighth, ninth, tenth, eleven and twelve thoracic spine. Cun is a distance measure unit used in locating acupoints in traditional Chinese medicine (TCM) acupuncture, and the width of patient's thumb interphalangeal joint is regarded as one cun.
Changes in the mean level of serum uric acid from baseline.
The changes in the mean level of serum uric acid at 8 weeks after randomization compared to baseline
Time frame: At baseline, and at 8 weeks after randomization.
Changes in the mean level of serum uric acid from baseline.
The changes in the mean level of serum uric acid at 4, 12, 16, 20 weeks after randomization compared to baseline
Time frame: At baseline, at 4, 12, 16, and 20 weeks after randomization.
Effective rate of patients with serum uric acid ≤ 6.0 mg/dL
The ratio of patients with serum uric acid ≤ 6.0 mg/dL at weeks 4, 8, 12, 16 and 20 after randomization
Time frame: 4, 8, 12, 16 and 20 weeks after randomization
Effective rate of patients with serum uric acid ≤ 7.0 mg/dL
The ratio of patients with serum uric acid ≤ 7.0 mg/dL at weeks 4, 8, 12, 16 and 20 after randomization
Time frame: 4, 8, 12, 16 and 20 weeks after randomization
The proportion of patients with acute gouty arthritis
The proportion of patients with acute gouty arthritis per 4-week cycle after randomization.
Time frame: Weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Changes in body weight of patients
Changes in body weight of patients at 4, 8, 12, 16, and 20 weeks after randomization.
Time frame: 4, 8, 12, 16 and 20 weeks after randomization
Changes in the dose of intake of acute medication.
The changes in the dose of intake of acute medication per 4-week cycle after randomization.
Time frame: Weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.
Arrival of qi assessment
The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale Acupuncture sensations will be measured by the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)
Time frame: Immediately following each session of acupuncture treatment.
Safety evaluation
Adverse events during the acupuncture process
Time frame: Immediately following each session of acupuncture treatment.
60-item NEO Personality Inventory-Short Form (NEO-FFI)
Time frame: At baseline only once.
Chinese medicine constitution classification
Time frame: At baseline only once.
Acupuncture Expectancy Scale
Time frame: At baseline only once.
Change in Beck Anxiety Inventory(BAI).
Time frame: At baseline only once.
Change in Beck Depression Inventory II(BDI- II).
Time frame: At baseline only once.
Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) .
Time frame: At baseline only once.
Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10).
Time frame: At baseline only once.
Started Jul 2022 (actual). Primary completion is estimated for Dec 2024, 29 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 29 months is above that.
How these figures are worked out, and which studies are left out of them.
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