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

Primary Purpose

"Hyperuricemia,Anserine"

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Marine active
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for "Hyperuricemia,Anserine"

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University HospitaRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
November 26, 2010
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00208000
Brief Title
A Clinical Double Blind, Randomized Study of the Efficacy of Hyperuricemia Treatment With Anserine Product.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
"Hyperuricemia,Anserine"

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Marine active

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiu-Shong Liu, Director
Phone
886-4-22052121
Ext
5068
Email
huangimd@lsc.net.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Kuo-Chin Huang
Phone
886-4-22052121
Ext
5068
Email
huangimd@lsc.net.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiu-Shong Liu, Director
Organizational Affiliation
Family Medicine, China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospita
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiu-Shong Liu, PhD
Phone
886-4-22052121
Ext
5068
Email
huang@lsc.net.tw
First Name & Middle Initial & Last Name & Degree
Kuo-Chin Huang, PhD
Phone
886-4-22052121
Ext
5068
Email
huang@lsc.net.tw

12. IPD Sharing Statement

Learn more about this trial

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

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