Dietary SupplementNCT04438486
Effects of Barley Green in Patients With Hyperuricemia
A study testing Group A and Group B in people with Dietary Supplement, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dietary Supplement
- What is being tested?
- Group A and Group B
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 6 sitesChina
- Study dates
- 1 Apr 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing
Hanping Shi, 01063926617
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Pianhong Zhang, MD, +86 057187783852, zrlcyyzx@zju.edu.cn
- Recruiting
Zhejiang cancer hospital
Hangzhou, Zhejiang, 310022
Sa Ye, 057188122222
- Recruiting
Jinhua municipal central hospital
Jinhua, Zhejiang, 321000
Guifen Hu, 057982338512
- Recruiting
Quzhou Kecheng People's Hospital
Quzhou, Zhejiang, 324000
Qiuxia Chen, 05708877120
- Recruiting
The first affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, 325000
Binbin Gu, 057755578033
About this study
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.
- Conditions
- Dietary Supplement
- Being tested
- Group A, Group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ABehavioural
specific dietary advice for Hyperuricemia
Group BDietary supplement
Barely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A
| Study group | Role | What they receive |
|---|---|---|
| dietary advice | Active comparator | Not described Receives: Behavioral: Group A |
| dietary advice+ Barely Green | Experimental | Not described Receives: Dietary Supplement: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
uric acid level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Apr 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438486
- Sponsor's protocol ID
- 2019-411
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Barley Green in Patients With Hyperuricemia
- ClinicalTrials.gov ID
- NCT04438486
- Acronym / sponsor ID
- 2019-411
- Conditions
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- 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
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dietary advice | Active comparator | Behavioral: Group A |
| dietary advice+ Barely Green | Experimental | Dietary Supplement: Group B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Aspecific dietary advice for Hyperuricemia | Behavioural | dietary advice |
| Group BBarely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A | Dietary supplement | dietary advice+ Barely Green |
Primary outcome
uric acid level
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Dietary Supplement, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pianhong Zhang, MS (+86057187783852, zrlcyyzx@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
uric acid level (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.