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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00208000
Enrollment
Unknown
Registered
2005-09-21
Start date
2004-07-31
Completion date
2006-04-30
Last updated
2010-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperuricemia,Anserine

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.

Interventions

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Countries

Taiwan

Contacts

Primary ContactChiu-Shong Liu, Director
huangimd@lsc.net.tw886-4-22052121
Backup ContactKuo-Chin Huang
huangimd@lsc.net.tw886-4-22052121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026