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A randomized controlled clinical study on the treatment of asymptomatic hyperuricemia with Jianpi Jiangzhuo Tang

A randomized controlled clinical study on the treatment of asymptomatic hyperuricemia with Jianpi Jiangzhuo Tang

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086904
Enrollment
Unknown
Registered
2024-07-15
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asymptomatic hyperuricemia

Interventions

Experimental Group:Administration of Jianpi Jiangzhuo Decoction Granules
Control Group:Administration of Chinese Medicine Granule Placebo

Sponsors

Beijing Pinggu District Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Western Medicine Diagnostic Criteria: Formulated with reference to the "Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout" in 2019: Under normal dietary conditions, two tests conducted on different days show that the fasting blood uric acid level is >420µmol/L (for adults, regardless of gender), and there has been no occurrence of gout attacks. Traditional Chinese Medicine (TCM) Diagnostic Criteria: Based on the relevant content of "Spleen Qi Deficiency Syndrome" and "Turbid Phlegm Obstruction Syndrome" in the "Guiding Principles for Clinical Research on New Chinese Medicines", the TCM syndrome type of "Spleen Deficiency and Turbid Obstruction Syndrome" for AHUA is formulated as follows: Main Symptoms: Poor appetite, fatigue and heaviness in the limbs, postprandial abdominal distension, abnormal bowel movements (loose, mushy, initially hard then loose, alternately loose and hard); obesity, heavy sensation in the head as if wrapped, chest congestion and epigastric distension, nausea with phlegm. Secondary Symptoms: Mental fatigue, reluctance to speak, bland taste without thirst, lingering abdominal pain, palpitations, insomnia. Tongue and Pulse Conditions: Pale and swollen tongue, thin and greasy tongue coating, slippery pulse. The diagnosis can be made based on three main symptoms combined with tongue and pulse conditions, or two main symptoms plus two secondary symptoms combined with tongue and pulse conditions. Inclusion Criteria: ? Meet both Western medicine and TCM diagnostic criteria; ? Fasting blood uric acid level <540µmol/L; ? Age range of 18 to 65 years, regardless of gender; ? Voluntarily participate, sign the informed consent form, and are able to accept long-term follow-up.

Exclusion criteria

Exclusion criteria: ?Patients with secondary hyperuricemia (HUA), such as those with tumors, hematological diseases, kidney diseases, or chronic poisoning; ?Individuals with severe cardiovascular and cerebrovascular diseases, malignant hypertension, acute infections, or thrombocytopenic hemorrhagic diseases; ?Those who have recently taken medications that can cause an increase in blood uric acid levels, such as thiazide diuretics, aspirin, levodopa, or ethambutol; ?Pregnant or lactating women; ?Patients with severe liver or kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
Blood uric acid level;

Secondary

MeasureTime frame
Body Mass Index;Scoring of symptoms and syndromes in Traditional Chinese Medicine;

Countries

China

Contacts

Public ContactShen Bin

Beijing Pinggu District Hospital of Traditional Chinese Medicine

13811578685@163.com+86 138 1157 8685

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026