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

June 7, 2016 updated by: Yuan Zhang, Guangzhou General Hospital of Guangzhou Military Command
The purpose of this study is to confirm the protective effect and mechanism of anthocyanins on hyperuricemia patients with Cardiovascular disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 020
        • Recruiting
        • General Hospital of Guangzhou Military Command of People's Liberation Army
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo capsule
Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. Control group taking placebo capsule
Dietary supplement: Placebo capsule
Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
Experimental: Anthocyanidins capsule
Simple hyperuricemia patients and with coronary heart disease in hospital. Double blind, randomized method. The experimental group taking anthocyanins capsule.
Dietary supplement: Anthocyanidins capsule
Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
Experimental: Allopurinol
The experimental group taking allopurinol.
Drug: Allopurinol
Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of serum uric acid levels in all patients
Time Frame: up to 1 months
Serum uric acid (mg/dl) is determined by Uric Acid kit on an automated system.
up to 1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of advanced glycation end products and its receptor level in all patients
Time Frame: up to 2 months
Advanced glycation end products and its receptor level are determined by high efficiency liquid chromatography.
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Collaborators

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 13, 2016

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 81402671

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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