Back to resultsEffects of Barley Green in Patients With Hyperuricemia
Primary Purpose
Dietary Supplement
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Group A
Group B
Sponsored by
About this trial
This is an interventional treatment trial for Dietary Supplement
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years old those who are willing to accept assessment and sign informed consent.
- Under the normal purine diet, two fasting blood uric acid levels on different days: 420umol/l <blood uric acid <540 umol/l (male), 360 umol/l <blood uric acid <540 umol/l (female)
Exclusion Criteria:
- Patients currently receiving treatment for hyperuricemia；
- Suffering from diseases that affect the digestion and absorption(such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcers, 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 active substances, health food);
- Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeds 3 times the upper limit of normal value); patients with abnormal 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 to participate in the study (for example, suffering from serious diseases not included in the discharge criteria)；
- Gouty arthritis attack ≥ 2 times;
- One episode of gouty arthritis with blood uric acid >480 umol/l, or any of the following: age <40 years old, evidence of gout stone or urate deposition in the joint cavity, uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronary heart disease, stroke, cardiac insufficiency;
- Blood uric acid>480 umol/l combined with any of the following: uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke, heart failure.
Sites / Locations
- The Second Affiliated Hospital, Zhejiang University School of MedicineRecruiting
- Zhejiang cancer hospitalRecruiting
- Jinhua municipal central hospitalRecruiting
- Quzhou Kecheng People's HospitalRecruiting
- The first affiliated hospital of Wenzhou medical universityRecruiting
- Beijing Shijitan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
dietary advice
dietary advice+ Barely Green
Arm Description
Outcomes
Primary Outcome Measures
uric acid level
Secondary Outcome Measures
Full Information
NCT ID
NCT04438486
First Posted
June 17, 2020
Last Updated
August 3, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jinhua Municipal Central Hospital, Quzhou Kecheng People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Cancer Hospital, Beijing Shijitan Hospital, Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04438486
Brief Title
Effects of Barley Green in Patients With Hyperuricemia
Official Title
Effects of Barley Green in Patients With Hyperuricemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jinhua Municipal Central Hospital, Quzhou Kecheng People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Zhejiang Cancer Hospital, Beijing Shijitan Hospital, Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dietary advice
Arm Type
Active Comparator
Arm Title
dietary advice+ Barely Green
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Group A
Intervention Description
specific dietary advice for Hyperuricemia
Intervention Type
Dietary Supplement
Intervention Name(s)
Group B
Intervention Description
Barely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A
Primary Outcome Measure Information:
Title
uric acid level
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65 years old those who are willing to accept assessment and sign informed consent.
Under the normal purine diet, two fasting blood uric acid levels on different days: 420umol/l <blood uric acid <540 umol/l (male), 360 umol/l <blood uric acid <540 umol/l (female)
Exclusion Criteria:
Patients currently receiving treatment for hyperuricemia；
Suffering from diseases that affect the digestion and absorption(such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcers, 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 active substances, health food);
Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeds 3 times the upper limit of normal value); patients with abnormal 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 to participate in the study (for example, suffering from serious diseases not included in the discharge criteria)；
Gouty arthritis attack ≥ 2 times;
One episode of gouty arthritis with blood uric acid >480 umol/l, or any of the following: age <40 years old, evidence of gout stone or urate deposition in the joint cavity, uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, coronary heart disease, stroke, cardiac insufficiency;
Blood uric acid>480 umol/l combined with any of the following: uric acid nephrolithiasis or renal impairment (GFR≤89ml/(min·1.73m2)), hypertension, impaired glucose tolerance or diabetes, dyslipidemia, obesity, Coronary heart disease, stroke, heart failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pianhong Zhang, MS
Phone
+86057187783852
Email
zrlcyyzx@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxu Huang, MS
Phone
+8618067961987
Email
xiaoxuhuang0909@zju.edu.cn
Facility Information:
Facility Name
The Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pianhong Zhang, MD
Phone
+86 057187783852
Email
zrlcyyzx@zju.edu.cn
Facility Name
Zhejiang cancer hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sa Ye
Phone
057188122222
Facility Name
Jinhua municipal central hospital
City
Jinhua
State/Province
Zhejiang
ZIP/Postal Code
321000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guifen Hu
Phone
057982338512
Facility Name
Quzhou Kecheng People's Hospital
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuxia Chen
Phone
05708877120
Facility Name
The first affiliated hospital of Wenzhou medical university
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binbin Gu
Phone
057755578033
Facility Name
Beijing Shijitan Hospital
City
Beijing
ZIP/Postal Code
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanping Shi
Phone
01063926617
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Barley Green in Patients With Hyperuricemia
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