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NCT02213562 Clinical Trial

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

Hyperuricemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02213562
Other study ID # eki-997
Secondary ID
Status Completed
Phase N/A
First received August 8, 2014
Last updated August 15, 2016
Start date July 2014
Est. completion date March 2016

Study information
Verified date August 2016
Source Hiroshima University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 30 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• 200 mg of chrysanthemum flower oil

• 300 mg of chrysanthemum flower oil

• 400 mg of chrysanthemum flower oil

Locations
Country Name City State
Japan Hiroshima University Hiroshima

Sponsors (2)
Lead Sponsor Collaborator
Hiroshima University Kaneka Corporation

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in serum uric acid from baseline Every 4 weeks (Overall 8 weeks) No
Primary Change in uric acid clearance from baseline Every 4 weeks (Overall 8 weeks) No
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