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Not yet recruitingNCT05913310Updated Jun 22, 2023

Efficacy and Safety of Kui-Yuan Chewable Tablets in Patients With Hyperuricemia

A Phase 4 interventional study of Kui-Yuan Chewable Tablets and Placedo of Kui-Yuan Chewable Tablets in Hyperuricemia, sponsored by Quan Jiang. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Quan Jiang · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Kui-Yuan chewable tablets in patients with hyperuricemia.

02

Conditions studied

  • Hyperuricemia

Browse trials for

Keywords

  • Hyperuricemia
  • Kui-Yuan Chewable
  • Randomized controlled trial
03

In context

Hyperuricemia

240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.

This study's planned enrollment of 126 is above the median of 68 across 193 interventional studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

Quan Jiang is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Blood uric acid level>7.0mg/dL (420 μmol/L)
  • The participants did not experience any acute gout attacks before treatment
  • The of the participants was normal before treatment

Exclusion criteria

Exclusion Criteria:

  • Secondary Hyperuricemia caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy, organ transplantation, etc
  • Those who have used allopurinol, probenecid, benzbromarone, febuxostat or traditional Chinese medicine with uric acid lowering effect within 4 weeks before enrollment
  • Those who had a history of cardiovascular and cerebrovascular diseases such as stroke, , MI, HF ( grade II-IV), and coronary artery surgery (such as angioplasty, stent implantation, bypass grafting, etc.)
  • Those who had a history of gastrointestinal ulcers or gastrointestinal bleeding
  • Active liver disease or abnormal liver function, and AST are more than 3 times the
  • (eGFR)\<30mL/min/1.73m2
  • Those who are allergic or intolerant to any component in Kui-Yuan chewable tablets and placebo
  • Those who had other diseases
  • Those who are taking or need to take aspirin, other salicylic acids, heparin, Dicoumarol and other anticoagulants and antiplatelet aggregation drugs
  • Those who taking Diuretic
  • Those who had a history of alcohol or drug dependence, or those who require long-term daily use of painkillers for any reason
  • Pregnancy, lactation, or planned pregnancy within 3 months after the last study medication
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • Active comparator
    Kui-Yuan Chewable Tablets

    Drug: Kui-Yuan Chewable Tablets

  • Placebo comparator
    Placebo of Kui-Yuan Chewable Tablets

    Drug: Placedo of Kui-Yuan Chewable Tablets

Interventions

  • DrugKui-Yuan Chewable Tablets

    Kui-Yuan chewable tablets are the optimal ingredients found in sunflower dish that can reduce uric acid and anti-gout, including flavonoids, Coumarin (including scopolamine) and phenolic acids.

  • DrugPlacedo of Kui-Yuan Chewable Tablets

    Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.

06

What researchers measure

Primary outcomes

  1. Proportion of sUA levels below 420 μmol/L

    Proportion of participants maintaining sUA levels below 420 μmol/L at the third month

    Time frame: 3 months

Secondary outcomes

  1. Proportion of sUA levels below 360 μmol/L

    Proportion of participants maintaining sUA levels below 360 μmol/L at the third month

    Time frame: 3 months

  2. The number of gout attacks

    The number of gout attacks from baseline to month 3

    Time frame: 3 months

  3. Proportion of gout attacks

    Proportion of participants reporting gout attacks from baseline to month 3

    Time frame: 3 months

  4. Percentage change in sUA levels

    Percentage change of participants in sUA levels from baseline to each visit

    Time frame: 3 months

  5. Changes in BMI

    Changes in participants' BMI from baseline to the third month (combined with obesity)

    Time frame: 3 months

  6. Changes in blood pressure levels

    Changes in participants' blood pressure levels from baseline to the third month (combined with hypertension)

    Time frame: 3 months

  7. Changes in blood lipid levels

    Changes in participants' blood lipid levels from baseline to the third month (combined with hyperlipidemia)

    Time frame: 3 months

  8. Changes in fasting blood glucose levels

    Changes in participants' fasting blood glucose levels from baseline to the third month (combined with diabetes)

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2023; primary completion for Jul 2024, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 9, 2023
First posted
Jun 22, 2023
StartEst.
Jul 2023
Primary completionEst.
Jul 2024
CompletionEst.
Aug 2024
Last update
Jun 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05913310
Lead sponsor
Quan Jiang
Responsible party
Quan Jiang (chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences) — Sponsor-investigator
First posted
Jun 22, 2023
Start date
Jul 2023 (estimated)
Primary completion
Jul 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Jun 22, 2023

Study contacts

Quan Jiang, M.D
Contact
doctorjq@126.com
+8613901081632

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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