Investigation of the Atherogenic Effects of Uric Acid-modified in Endothelial Dysfunction and the the Preventional Mechanism by Anthocyanidines

Guangzhou General Hospital of Guangzhou Military Command

Status and phase: Unknown; Phase 4

Conditions: Cardiovascular Disease

Treatments: Dietary Supplement: Placebo capsule; Dietary Supplement: Anthocyanidins capsule; Drug: Allopurinol

Study type: Interventional

Funder types: Other

Identifiers

NCT02797028

No. 81402671

Details and patient eligibility

About

The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.

Full description

Hyperuricemia patients who have the ability to complete the intervention study in the early stage of study were selected as the research subjects. A randomized controlled double blind control method was used to study the effect of one year of anthocyanins intervention. Serum UA levels, oxidative stress, AGEs, and endothelial function are detecting in patients with hyperuricemia who were treated with anthocyanins and placebo. Providing scientific basis of anthocyanins for the treatment with hyperuricemia and delaying atherosclerosis.

Enrollment: 320 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Serum uric acid >420μmol/L (7mg/dL) in male, >360μmol/L (6mg/dL) in female identified as hyperuricemia patients.

Exclusion criteria

• Age more than 60 years and less than 30 years old;
• acute infection, tumor, recent surgery, need for hemodialysis and autoimmune diseases.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

320 participants in 3 patient groups, including a placebo group

Placebo capsule

Placebo Comparator group

Description:

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule

Treatment:

Dietary Supplement: Placebo capsule

Anthocyanidins capsule

Experimental group

Description:

Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule.

Treatment:

Dietary Supplement: Anthocyanidins capsule

Allopurinol

Experimental group

Description:

The experimental group taking allopurinol.

Treatment:

Drug: Allopurinol