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

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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

Study Description
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Brief Summary:
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid.

Condition or disease Intervention/treatment Phase
Hyperuricemia Dietary Supplement: 200 mg of chrysanthemum flower oil Dietary Supplement: 300 mg of chrysanthemum flower oil Dietary Supplement: 400 mg of chrysanthemum flower oil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Chrysanthemum Flower Oil and Its Dose-dependency in Subjects With Hyperuricemia
Study Start Date : July 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: 200 mg CFO
200 mg of chrysanthemum flower oil
 Dietary Supplement: 200 mg of chrysanthemum flower oil
Experimental: 300 mg CFO
300 mg of chrysanthemum flower oil
 Dietary Supplement: 300 mg of chrysanthemum flower oil
Experimental: 400 mg CFO
400 mg of chrysanthemum flower oil
 Dietary Supplement: 400 mg of chrysanthemum flower oil


Outcome Measures
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Primary Outcome Measures :
  1. Change in serum uric acid from baseline [ Time Frame: Every 4 weeks (Overall 8 weeks) ]
  2. Change in uric acid clearance from baseline [ Time Frame: Every 4 weeks (Overall 8 weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213562


Locations
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Japan
Hiroshima University
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Kaneka Corporation
Investigators
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Principal Investigator: Fumiko Higashikawa, PhD Hiroshima University
More Information
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Responsible Party: Fumiko Higashikawa, Associate Professor, Hiroshima University
ClinicalTrials.gov Identifier: NCT02213562     History of Changes
Other Study ID Numbers: eki-997
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes