NCT02213562

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

August 8, 2014

Last Update Submit

August 15, 2016

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (2)

  • Change in serum uric acid from baseline

    Every 4 weeks (Overall 8 weeks)

  • Change in uric acid clearance from baseline

    Every 4 weeks (Overall 8 weeks)

Study Arms (3)

200 mg CFO

EXPERIMENTAL

200 mg of chrysanthemum flower oil

Dietary Supplement: 200 mg of chrysanthemum flower oil

300 mg CFO

EXPERIMENTAL

300 mg of chrysanthemum flower oil

Dietary Supplement: 300 mg of chrysanthemum flower oil

400 mg CFO

EXPERIMENTAL

400 mg of chrysanthemum flower oil

Dietary Supplement: 400 mg of chrysanthemum flower oil

Interventions

200 mg of chrysanthemum flower oilDIETARY_SUPPLEMENT
200 mg CFO
300 mg of chrysanthemum flower oilDIETARY_SUPPLEMENT
300 mg CFO
400 mg of chrysanthemum flower oilDIETARY_SUPPLEMENT
400 mg CFO

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Serum uric acid 6.8-8.9 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fumiko Higashikawa, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 11, 2014

Study Start

July 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

JP(1)