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Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02213562
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : August 17, 2016
Sponsor:
Collaborator:
Kaneka Corporation
Information provided by (Responsible Party):
Fumiko Higashikawa, Hiroshima University

Tracking Information
First Submitted Date  ICMJE August 8, 2014
First Posted Date  ICMJE August 11, 2014
Last Update Posted Date August 17, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
  • Change in serum uric acid from baseline [ Time Frame: Every 4 weeks (Overall 8 weeks) ]
  • Change in uric acid clearance from baseline [ Time Frame: Every 4 weeks (Overall 8 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02213562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia
Official Title  ICMJE A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Chrysanthemum Flower Oil and Its Dose-dependency in Subjects With Hyperuricemia
Brief Summary The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hyperuricemia
Intervention  ICMJE
  • Dietary Supplement: 200 mg of chrysanthemum flower oil
  • Dietary Supplement: 300 mg of chrysanthemum flower oil
  • Dietary Supplement: 400 mg of chrysanthemum flower oil
Study Arms  ICMJE
  • Experimental: 200 mg CFO
    200 mg of chrysanthemum flower oil
    Intervention: Dietary Supplement: 200 mg of chrysanthemum flower oil
  • Experimental: 300 mg CFO
    300 mg of chrysanthemum flower oil
    Intervention: Dietary Supplement: 300 mg of chrysanthemum flower oil
  • Experimental: 400 mg CFO
    400 mg of chrysanthemum flower oil
    Intervention: Dietary Supplement: 400 mg of chrysanthemum flower oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 8, 2014)
21
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Serum uric acid 6.8-8.9 mg/dL

Exclusion Criteria:

  • Taking anti-hyperuricemic drugs
  • History of gouty attack
  • Taking drugs or functional food that may affect serum uric acid level
  • Hypertention, hyperlipidemia, or diabetes millitus
  • Participation in any clinical trial within 90 days of the commencement of the trial
  • Renal or hepatic dysfunction
  • Heart disease
  • History of severe disease and/or major surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213562
Other Study ID Numbers  ICMJE eki-997
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fumiko Higashikawa, Hiroshima University
Study Sponsor  ICMJE Hiroshima University
Collaborators  ICMJE Kaneka Corporation
Investigators  ICMJE
Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University
PRS Account Hiroshima University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP