Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02797028
Recruitment Status : Unknown
Verified June 2016 by Yuan Zhang, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was:  Recruiting
First Posted : June 13, 2016
Last Update Posted : June 13, 2016
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Yuan Zhang, Guangzhou General Hospital of Guangzhou Military Command

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

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Anthocyanidins capsule Dietary Supplement: Placebo capsule Drug: Allopurinol Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : January 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Allopurinol

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797028


Contacts
Layout table for location contacts
Contact: Hui Dai 020-36653321 daihui66@sina.com
Contact: Yuan Zhang 020-61653566 1035834805@qq.com

Locations
Layout table for location information
China, Guangdong
General Hospital of Guangzhou Military Command of People's Liberation Army Recruiting
Guangzhou, Guangdong, China, 020
Contact: Hui Dai    020-36653321    daihui66@sina.com   
Contact: Yuan Zhang    020-61653566    1035834805@qq.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
Sun Yat-sen University

Publications:
Layout table for additonal information
Responsible Party: Yuan Zhang, Doctor of Medicine, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02797028     History of Changes
Other Study ID Numbers: No. 81402671
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016

Keywords provided by Yuan Zhang, Guangzhou General Hospital of Guangzhou Military Command:
Hyperuricemia
endothelial function
anthocyanidins

Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Proanthocyanidin
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents