Last updated: August 3, 2021
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Gout (Hyperuricemia)
Treatment
N/AClinical Study ID
NCT04438486
2019-411
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-65 years old those who are willing to accept assessment and sign informedconsent.
- Under the normal purine diet, two fasting blood uric acid levels on different days: 420umol/l
Exclusion
Exclusion Criteria:
- Patients currently receiving treatment for hyperuricemia;
- Suffering from diseases that affect the digestion and absorption(such as chronicdiarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinalulcers, after gastrointestinal resection, cholecystitis/cholecystectomy, etc.);
- Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension,chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders,epilepsy and other diseases;
- At the same time receive other functional food nutrition support (plant activesubstances, health food);
- Patients with abnormal liver function (alanine aminotransferase or/and aspartateaminotransferase exceeds 3 times the upper limit of normal value); patients withabnormal renal function (serum creatinine exceeds the upper limit of normal value);
- Suffering from infectious diseases such as active tuberculosis and AIDS;
- People who are severely allergic to the ingredients of research;
- During pregnancy or lactation;
- Patients with physical disabilities and clinicians think it is not suitable toparticipate in the study (for example, suffering from serious diseases not included inthe discharge criteria);
- Gouty arthritis attack ≥ 2 times;
- One episode of gouty arthritis with blood uric acid >480 umol/l, or any of thefollowing: age <40 years old, evidence of gout stone or urate deposition in the jointcavity, uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)),hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronaryheart disease, stroke, cardiac insufficiency;
- Blood uric acid>480 umol/l combined with any of the following: uric acidnephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impairedglucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke,heart failure.
Study Design
Total Participants: 130
Study Start date:
April 01, 2020
Estimated Completion Date:
July 01, 2022
Connect with a study center
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
Zhejiang cancer hospital
Hangzhou, Zhejiang 310022
ChinaActive - Recruiting
Jinhua municipal central hospital
Jinhua, Zhejiang 321000
ChinaActive - Recruiting
Quzhou Kecheng People's Hospital
Quzhou, Zhejiang 324000
ChinaActive - Recruiting
The first affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang 325000
ChinaActive - Recruiting
Beijing Shijitan Hospital
Beijing, Beijing
ChinaActive - Recruiting
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