Effect of Chrysanthemum Flower Oil and Its Dose-dependenc... | NCT02213562

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

NCT02213562

Sponsor

Hiroshima University

Status

Completed

Last Update Posted

Aug 17, 2016Estimated

Enrollment

21Estimated

Phase

Not Applicable

Conditions

Hyperuricemia

Interventions

200 mg of chrysanthemum flower oil
300 mg of chrysanthemum flower oil
400 mg of chrysanthemum flower oil

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Aug 8, 2014

First Submission Date that Met QC Criteria

Aug 8, 2014

First Posted Date

Aug 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2016

Last Update Posted Date

Aug 17, 2016Estimated

Name	Class
Kaneka Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
200 mg of chrysanthemum flower oil	Dietary Supplement		200 mg CFO
300 mg of chrysanthemum flower oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fumiko Higashikawa, PhD	Hiroshima University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima		734-8551	Japan

Condition Browse Module

MeSH Terms

ID	Term
D033461	Hyperuricemia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided