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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00208000
First received: September 16, 2005
Last updated: November 26, 2010
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
"Hyperuricemia,Anserine"
Drug: Marine active
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further study details as provided by China Medical University Hospital:

Study Start Date: July 2004
Estimated Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208000

Contacts
Contact: Chiu-Shong Liu, Director 886-4-22052121 ext 5068 huangimd@lsc.net.tw
Contact: Kuo-Chin Huang 886-4-22052121 ext 5068 huangimd@lsc.net.tw

Locations
Taiwan
China Medical University Hospita Recruiting
Taichung, Taiwan, 404
Contact: Chiu-Shong Liu, PhD    886-4-22052121 ext 5068    huang@lsc.net.tw   
Contact: Kuo-Chin Huang, PhD    886-4-22052121 ext 5068    huang@lsc.net.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chiu-Shong Liu, Director Family Medicine, China Medical University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00208000     History of Changes
Other Study ID Numbers: DMR93-IRB-22
Study First Received: September 16, 2005
Last Updated: November 26, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014