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| ID | Type | Description | Link |
|---|---|---|---|
| ZY2021Z002 | Other Grant/Funding Number | TCM Scientific Research Project of Hubei Provincial Health Commission |
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| Name | Class |
|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Xianning Hospital of Traditional Chinese Medicine, China | UNKNOWN |
| Beijing Hospital of Traditional Chinese Medicine |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual acupuncture group | Experimental | Acupuncturists will apply 20 sessions of 30-mintute manual acupuncture at 10 obligatory acupoints, over 8 weeks of treatment period. |
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| Sham acupuncture group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum uric acid (SUA) | Changes in the SUA level after 8 weeks of treatment. | Baseline and 8 weeks after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with SUA ≤ 6.0 mg/dL | The proportion of participants with SUA ≤ 6.0 mg/dL after treatment. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Changes in the body weight after treatment. | baseline, 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. |
| Abdominal circumference |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shenghao Tu, PhD | Contact | 86-13971535353 | shtu@tjh.tjmu.edu.cn | |
| Lingling Yu, PhD | Contact | 86-13545862185 | 527679774@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shenghao Tu, Ph.D | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
IPD after de-identification can be shared on individual request to the principal investigator at shtu@tjh.tjmu.edu.cn
IPD and supporting information will be available after the publication of the primary outcomes.
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| Qianjiang Central Hospital, China | UNKNOWN |
| Hainan General Hospital | OTHER |
| Yichang Central People's Hospital | OTHER |
| Wuhan No.1 Hospital | OTHER |
| The Second Hospital of Huangshi | UNKNOWN |
| Puyang Hospital of Traditional Chinese Medicine | UNKNOWN |
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| Sham acupuncture | Device | 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. |
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The proportion of participants with SUA ≤ 7.0 mg/dL after treatment. |
| 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. | 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 | 4 weeks after randomization, 8 weeks after randomization, 12 weeks after randomization and 16 weeks after randomization. |
Changes in abdominal circumference after treatment.
| 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) | 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 | 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. | 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. | 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 | 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. | 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 | Ten minutes after each manual or sham acupuncture treatment. |
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