A Clinical Double Blind, Randomized Study of the Efficacy of Hyperuricemia Treatment With Anserine Product.

Hyperuricemia is a common metabolic disorder.The Yaizu Suisankagaku Industry Company have developed industrial production named Marine Active, was able to offer anti-fatigue activity by animal trial data. Human clinical trials showed reduced creatine phosphokinase activity and a sero-uric acid reduction activity was also observed. So we are committed to design the clinical randomized, double blind study about hyperuricemia management with Marine Active. All these efforts are hoped to find a novel method to manage hyperuricemia.

Study Overview

• Status: Unknown
• Conditions: "Hyperuricemia,Anserine"
• Intervention / Treatment: Drug: Marine active

Detailed Description

Hyperuricemia is a common metabolic disorder. It can result from a decreased renal uric acid excretion, increased urate production, or both. The classical association with clinical gout is well-known. The principal indications for uric acid-lowering therapy, including allopurinol, probenecid and sulfinpyrazone, are the patients with gout history, macroscopic subcutaneous tophi, frequent attacks of gouty arthritis, or a documented state of uric acid overproduction. Hyperuricemia without gout attack is not an indication for treatment.However, hyperuricemia is often associated with other cardiovascular disease risk factors such as obese, hyperlipidemia, glucose intolerance and hypertension. It is known a symptom of syndrome X (also known as multiple risk factor clustering syndrome). Diet control is the only way to control serum uric acid level, but always it is not enough. So how to management hyperuricemia is important and is a potential management.Histidine-containing dipeptides such as Anserine and Carnosine have been studied extensively in recent years. These dipeptides were shown to be effective in acting as buffering agents against protons developed during anaerobic exercise. Anserine and Carnosine also have strong anti-oxidant activity, anti-cancer activity, immuno-response modulation, fat reduction and enhanced wound healing functions. The Yaizu Suisankagaku Industry Company have developed industrial production process to extract and purify the dipeptides from Bonito and Tuna. The extract, named Marine Active, was able to offer anti-fatigue activity by animal trial data. Human clinical trials showed reduced creatine phosphokinase activity and a sero-uric acid reduction activity was also observed. So we are committed to design the clinical randomized, double blind study about hyperuricemia management with Marine Active. All these efforts are hoped to find a novel method to manage hyperuricemia.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chiu-Shong Liu, Director; Phone Number: 5068 886-4-22052121; Email: huangimd@lsc.net.tw
• Study Contact Backup: Name: Kuo-Chin Huang; Phone Number: 5068 886-4-22052121; Email: huangimd@lsc.net.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • Recruiting
    • China Medical University Hospita
    • Contact: Chiu-Shong Liu, PhD; Phone Number: 5068 886-4-22052121; Email: huang@lsc.net.tw
    • Contact: Kuo-Chin Huang, PhD; Phone Number: 5068 886-4-22052121; Email: huang@lsc.net.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients, age between 18 to 60 years
• With the data of serum uric acid level more than 8.0 mg/dl within 2 weeks before the initiation of study
• Signed informed consent obtained prior to inclusion into the study

Exclusion Criteria:

• Pregnant women.
• Acute onset of gouty arthritis or renal stone
• Significant liver or renal dysfunction, hematological disease, oncological disease, or other life threatens disorders.
• Condition that need the management of diuretics or analgesics agent
• Have been administrated by anti-hyperuricemia agent or healthy food with in 4 weeks before the initiation of study.
• The serum uric acid level could be decrease to lower than 8 mg/dl by diet control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Chiu-Shong Liu, Director, Family Medicine, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion (ANTICIPATED): April 1, 2006

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (ESTIMATE): September 21, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): November 29, 2010
• Last Update Submitted That Met QC Criteria: November 26, 2010
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: DMR93-IRB-22