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Study on hydrolyzed casein peptides and compound products to lower uric acid and delay gout attacks

Study on hydrolyzed casein peptides and compound products to lower uric acid and delay gout attacks

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071493
Enrollment
Unknown
Registered
2023-05-16
Start date
2023-05-20
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia

Interventions

Hydrolyzed casein peptide complex group:Hydrolyzed Casein Peptide Compounding Products+Flavor correction agent + Color correction agent
Hydrolyzed casein peptide group:Hydrolyzed casein peptide+Flavor correction agent + Color correction agent
Placebo group:Flavor correction agent + Color correction agent

Sponsors

Medical College of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the above Western medical diagnostic standards; 2) Those who are older than or equal to 18 years old and less than or equal to 75 years old; 3) Patients with a history of gouty arthritis attacks, who have not had an attack within 1 month and are currently in a stable state; 4) Fasting blood glucose < 7.0mmol/L, blood glucose < 11.1mmol/L 2 hours after meals; 5) Have not taken other traditional Chinese medicines or uric acid-lowering drugs recently; 6) Those who have not used drugs that have serious effects on liver and kidney function within 3 months; 7) Sign the informed consent form, understand the content of the research, and be able to independently cooperate in completing the research.

Exclusion criteria

Exclusion criteria: 1) Patients with hyperuricemia who have previously developed gout; 2) Patients with urinary uric acid stones; 3) Patients with secondary hyperuricemia caused by other causes; 4) Patients with diabetes, cardiovascular and cerebrovascular, liver, kidney and other major diseases; 5) alcoholics, pregnant and lactating women and psychiatric patients; 6) Patients with severe allergies.

Design outcomes

Primary

MeasureTime frame
Serum uric acid decreases from baseline;

Secondary

MeasureTime frame
Four-level evaluation of clinical efficacy;Incidence of gout attacks;Measured change in erythrocyte sedimentation rate (ESR) from baseline;Measured changes in liver and kidney function (ALT, AST, BUN, Cr, GFR) from baseline;Measured change in C-reactive protein (CRP) from baseline;The measured changes of four lipids (TC, TG, HDL-C, LDL-G) from the baseline period;Measured change in fasting blood glucose (GLU) from baseline;Measured change in interleukin-lß (IL-lß) from baseline;Changes in urine pH from baseline, measured values and decreases;Measured and decreased changes in blood pressure from baseline;

Countries

China

Contacts

Public ContactJin Sun

Medical College of Qingdao University

sunj@qdu.edu.cn+86 181 5155 9959

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026