Back to results

Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia

Primary Purpose

Asymptomatic Hyperuricemia

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

verum acupuncture

health education

sham acupuncture

About this trial

This is an interventional treatment trial for Asymptomatic Hyperuricemia focused on measuring Manual Acupuncture, Asymptomatic Hyperuricemia, Serum Uric Acid, Efficacy, Safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
18.5kg/m2≤BMI≤30.0kg/ m2; and
Able to signing a informed consent.

Exclusion Criteria:

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%.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Verum acupuncture (VA)

Sham acupuncture (SA)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

The proportion of patients with acute gouty arthritis

The proportion of patients with acute gouty arthritis per 4-week cycle after randomization.

Changes in body weight of patients

Changes in body weight of patients at 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.

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)

Safety evaluation

Adverse events during the acupuncture process

Full Information

NCT ID

NCT05406830

First Posted

June 1, 2022

Last Updated

March 12, 2023

Sponsor

Tongji Hospital

Collaborators

Wuhan Integrated Traditional Chinese and Western Medicine Hospital, Xianning Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05406830

Brief Title

Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia

Official Title

Evaluating the Efficacy of Acupuncture for Patients With Asymptomatic Hyperuricemia (HUA): A Multicenter Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 13, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tongji Hospital

Collaborators

Wuhan Integrated Traditional Chinese and Western Medicine Hospital, Xianning Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asymptomatic Hyperuricemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Verum acupuncture (VA)

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture (SA)

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

verum acupuncture

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

health education

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

sham acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Secondary Outcome Measure Information:

Title

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

Description

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.

Title

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

Description

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

Title

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

Description

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

Title

The proportion of patients with acute gouty arthritis

Description

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.

Title

Changes in body weight of patients

Description

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

Title

Changes in the dose of intake of acute medication.

Description

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.

Title

Arrival of qi assessment

Description

Time Frame

Immediately following each session of acupuncture treatment.

Title

Safety evaluation

Description

Adverse events during the acupuncture process

Time Frame

Immediately following each session of acupuncture treatment.

Other Pre-specified Outcome Measures:

Title

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

Time Frame

At baseline only once.

Title

Chinese medicine constitution classification

Time Frame

At baseline only once.

Title

Acupuncture Expectancy Scale

Time Frame

At baseline only once.

Title

Change in Beck Anxiety Inventory(BAI).

Time Frame

At baseline only once.

Title

Change in Beck Depression Inventory II(BDI- II).

Time Frame

At baseline only once.

Title

Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) .

Time Frame

At baseline only once.

Title

Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10).

Time Frame

At baseline only once.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 18.5kg/m2≤BMI≤30.0kg/ m2; and Able to signing a informed consent. Exclusion Criteria: 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%.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lingling Yu, PhD

Phone

86-13545862185

527679774@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shenghao Tu, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

玲玲余

Phone

+8613545862185

527679774@qq.com

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia

We'll reach out to this number within 24 hrs