Effects of Barley Green in Patients With Hyperuricemia

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/A

Clinical Study ID

NCT04438486
2019-411
  • Ages 18-65
  • All Genders

Study Summary

This experiment evaluates the effect of Barley Green in patients with hyperuricemia , and explores the effect of Barley Green on metabolic indexes such as uric acid, blood lipids, blood glucose, free fatty acids。130 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (control group) will receive dietary guidance. Arm B will receive dietary guidance and Barley Green.

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
    China

    Active - Recruiting

  • Zhejiang cancer hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

  • Jinhua municipal central hospital

    Jinhua, Zhejiang 321000
    China

    Active - Recruiting

  • Quzhou Kecheng People's Hospital

    Quzhou, Zhejiang 324000
    China

    Active - Recruiting

  • The first affiliated hospital of Wenzhou medical university

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • Beijing Shijitan Hospital

    Beijing, Beijing
    China

    Active - Recruiting

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