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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
Hiroshima University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperuricemia

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

First Posted
August 8, 2014
Last Updated
August 15, 2016
Sponsor
Hiroshima University
Collaborators
Kaneka Corporation
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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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