Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia
NCT ID: NCT05406830
Last Updated: 2024-03-12
Study Results
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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RECRUITING
NA
180 participants
INTERVENTIONAL
2022-07-13
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Verum acupuncture (VA)
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.
verum 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.
health education
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.
Sham acupuncture (SA)
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.
health education
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.
sham acupuncture
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.
Interventions
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verum 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.
health education
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.
sham acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* Fasting blood uric acid level ≥ 7-11.0 mg/dL after 1 month of low-purine diet; and
* Without history of gouty arthritis; and
* Without drug treatment for hyperuricemia or stop uric acid-lowering drug treatment ≥12 weeks; and
* 18.5kg/m2≤BMI≤30.0kg/ m2; and
* Able to signing a informed consent.
Exclusion Criteria
* Patients are using or used other drugs that affect uric acid metabolism in the past 12 weeks, such as: thiazide diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, compound reserpine, pyrazinamide, nitrates fendipine, propranolol, and benzbromarone; and
* Patients have history of gouty arthritis; and
* Combined with secondary hyperurmicema, such as bone marrow and lymphoproliferative diseases, tumor radiotherapy and chemotherapy, liver cirrhosis and drug-induced hyperurmicema; and
* Combined with one of the following comorbidities: hypertension, diabetes, stroke, coronary heart disease, severe liver and kidney damage (≥CKD stage 2, or high creatinine, urea, glutamate, glutamate ≥ 2 times of the limit of clinical normal values); and
* Combined with severe neuropsychological diseases, such as severe anxiety, depression, and intellectual disability; and
* Pregnant women; and
* Unwilling to accept acupuncture treatment; and
* Illiterate, or patients unable to sign informed consent; and
* The completion rate of baseline screening data is ≤80%.
18 Years
65 Years
ALL
No
Sponsors
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Wuhan Integrated Traditional Chinese and Western Medicine Hospital
OTHER
Xianning Central Hospital
OTHER
Lingling Yu (103250)
OTHER
Responsible Party
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Lingling Yu (103250)
Professor
Principal Investigators
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Shenghao Tu, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan,430030, China
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
Countries
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Central Contacts
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Facility Contacts
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References
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Yu LL, Li CN, Fang MY, Ma Y, Wang B, Lin FP, Liu WH, Tu SH, Chen Z, Xie WX, Zhang RY, Huang Y, Zheng CH, Wang Y. Evaluating the effectiveness and safety of acupuncture on serum uric acid in asymptomatic hyperuricemia population: a randomized controlled clinical trial study protocol. Front Endocrinol (Lausanne). 2023 Oct 13;14:1218546. doi: 10.3389/fendo.2023.1218546. eCollection 2023.
Other Identifiers
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2021HUATJ01
Identifier Type: -
Identifier Source: org_study_id
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