HyperuricemiaNCT02213562
Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia
A study testing 200 mg of chrysanthemum flower oil, 300 mg of chrysanthemum flower oil and 400 mg of chrysanthemum flower oil in people with Hyperuricemia, run by Hiroshima University at 1 site in Japan.
Trial summary
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- 200 mg of chrysanthemum flower oil, 300 mg of chrysanthemum flower oil and 400 mg of chrysanthemum flower oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Serum uric acid 6.8-8.9 mg/dL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid.
- Conditions
- Hyperuricemia
- Being tested
- 200 mg of chrysanthemum flower oil, 300 mg of chrysanthemum flower oil, 400 mg of chrysanthemum flower oil
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg of chrysanthemum flower oilDietary supplement
300 mg of chrysanthemum flower oilDietary supplement
400 mg of chrysanthemum flower oilDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 200 mg CFO | Experimental | 200 mg of chrysanthemum flower oil Receives: Dietary Supplement: 200 mg of chrysanthemum flower oil |
| 300 mg CFO | Experimental | 300 mg of chrysanthemum flower oil Receives: Dietary Supplement: 300 mg of chrysanthemum flower oil |
| 400 mg CFO | Experimental | 400 mg of chrysanthemum flower oil Receives: Dietary Supplement: 400 mg of chrysanthemum flower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum uric acid from baseline
Measured: Every 4 weeks (Overall 8 weeks)
Change in uric acid clearance from baseline
Measured: Every 4 weeks (Overall 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaneka Corporation
- Responsible party
- Principal investigator, Fumiko Higashikawa, Hiroshima University
- Investigators
- Fumiko Higashikawa, PhD, Principal investigator, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213562
- Sponsor's protocol ID
- eki-997
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02213562
- Acronym / sponsor ID
- eki-997
- Conditions
- Hyperuricemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Collaborators
- Kaneka Corporation
- Study start
- Jul 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum flower oil in suppressing serum uric acid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200 mg CFO | Experimental | Dietary Supplement: 200 mg of chrysanthemum flower oil200 mg of chrysanthemum flower oil |
| 300 mg CFO | Experimental | Dietary Supplement: 300 mg of chrysanthemum flower oil300 mg of chrysanthemum flower oil |
| 400 mg CFO | Experimental | Dietary Supplement: 400 mg of chrysanthemum flower oil400 mg of chrysanthemum flower oil |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Serum uric acid 6.8-8.9 mg/dL
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 200 mg of chrysanthemum flower oil | Dietary supplement | 200 mg CFO |
| 300 mg of chrysanthemum flower oil | Dietary supplement | 300 mg CFO |
| 400 mg of chrysanthemum flower oil | Dietary supplement | 400 mg CFO |
Primary outcome
Change in serum uric acid from baseline
Time frame: Every 4 weeks (Overall 8 weeks)
Change in uric acid clearance from baseline
Time frame: Every 4 weeks (Overall 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fumiko Higashikawa, PhD principal investigator
Hiroshima University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 200 mg of chrysanthemum flower oil, 300 mg of chrysanthemum flower oil and 400 mg of chrysanthemum flower oil in people with Hyperuricemia, run by Hiroshima University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum uric acid from baseline (time frame: Every 4 weeks (Overall 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.