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

NCT ID: NCT00208000

Last Updated: 2010-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2006-04-30

Brief Summary

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.

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.

Conditions

"Hyperuricemia,Anserine"

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Marine active

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Chiu-Shong Liu, Director

Role: PRINCIPAL_INVESTIGATOR

Family Medicine, China Medical University Hospital

Locations

China Medical University Hospita

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chiu-Shong Liu, Director

Role: CONTACT

Phone: 886-4-22052121

Email: huangimd@lsc.net.tw

Kuo-Chin Huang

Role: CONTACT

Phone: 886-4-22052121

Email: huangimd@lsc.net.tw

Facility Contacts

Chiu-Shong Liu, PhD

Role: primary

Kuo-Chin Huang, PhD

Role: backup

Other Identifiers

DMR93-IRB-22

Identifier Type: -

Identifier Source: org_study_id