Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia

NCT05406830 | Recruiting DMC

• 1 other identifier: 2021HUATJ01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asymptomatic Hyperuricemia

Keywords

Manual Acupuncture; Asymptomatic Hyperuricemia; Serum Uric Acid; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline, and at 8 weeks after randomization.

Secondary Outcomes (8)

• Changes in the mean level of serum uric acid from baseline.

  At baseline, at 4, 12, 16, and 20 weeks after randomization.

• Effective rate of patients with serum uric acid ≤ 6.0 mg/dL

  4, 8, 12, 16 and 20 weeks after randomization

• Effective rate of patients with serum uric acid ≤ 7.0 mg/dL

  4, 8, 12, 16 and 20 weeks after randomization

• The proportion of patients with acute gouty arthritis

  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

  4, 8, 12, 16 and 20 weeks after randomization

Other Outcomes (7)

• 60-item NEO Personality Inventory-Short Form (NEO-FFI)

  At baseline only once.

• Chinese medicine constitution classification

  At baseline only once.

• Acupuncture Expectancy Scale

  At baseline only once.

Study Arms (2)

Verum acupuncture (VA)

EXPERIMENTAL

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

Sham acupuncture (SA)

SHAM COMPARATOR

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

Interventions

verum acupuncture DEVICE

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.

Verum acupuncture (VA)

health education BEHAVIORAL

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); Verum acupuncture (VA)

sham acupuncture DEVICE

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.

Sham acupuncture (SA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as hyperuricemia; and
• 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
• kg/m2≤BMI≤30.0kg/ m2; and
• Able to signing a informed consent.

You may not qualify if:

• Those who are using or have used one of the following drugs for the treatment of hyperuricemia 12 weeks before eligibility evaluation, such as: allopurinol, benzbromarone, probesulfan, bugelone, toppirosteine, Busotan; and
• 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%.

Sponsors & Collaborators

• Lingling Yu (103250): lead
• Wuhan Integrated Traditional Chinese and Western Medicine Hospital: collaborator
• Xianning Central Hospital: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37900149 DERIVED

Study Officials

• Shenghao Tu, PhD

  Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan,430030, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingling Yu, PhD

CONTACT

86-13545862185; 527679774@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: July 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CN (1)