Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia
Primary Purpose
Hyperuricemia
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
200 mg of chrysanthemum flower oil
300 mg of chrysanthemum flower oil
400 mg of chrysanthemum flower oil
Sponsored by
About this trial
This is an interventional prevention trial for Hyperuricemia
Eligibility 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
Sites / Locations
- Hiroshima University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
200 mg CFO
300 mg CFO
400 mg CFO
Arm Description
200 mg of chrysanthemum flower oil
300 mg of chrysanthemum flower oil
400 mg of chrysanthemum flower oil
Outcomes
Primary Outcome Measures
Change in serum uric acid from baseline
Change in uric acid clearance from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT02213562
First Posted
August 8, 2014
Last Updated
August 15, 2016
Sponsor
Hiroshima University
Collaborators
Kaneka Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02213562
Brief Title
Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hiroshima University
Collaborators
Kaneka Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
200 mg CFO
Arm Type
Experimental
Arm Description
200 mg of chrysanthemum flower oil
Arm Title
300 mg CFO
Arm Type
Experimental
Arm Description
300 mg of chrysanthemum flower oil
Arm Title
400 mg CFO
Arm Type
Experimental
Arm Description
400 mg of chrysanthemum flower oil
Intervention Type
Dietary Supplement
Intervention Name(s)
200 mg of chrysanthemum flower oil
Intervention Type
Dietary Supplement
Intervention Name(s)
300 mg of chrysanthemum flower oil
Intervention Type
Dietary Supplement
Intervention Name(s)
400 mg of chrysanthemum flower oil
Primary Outcome Measure Information:
Title
Change in serum uric acid from baseline
Time Frame
Every 4 weeks (Overall 8 weeks)
Title
Change in uric acid clearance from baseline
Time Frame
Every 4 weeks (Overall 8 weeks)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumiko Higashikawa, PhD
Organizational Affiliation
Hiroshima University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hiroshima University
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
12. IPD Sharing Statement
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Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia
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