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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000045705
Receipt No. R000052159
Scientific Title Pharmacokinetic studies of curcumin-containing supplements in humans
Date of disclosure of the study information 2021/10/08
Last modified on 2021/10/11

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Basic information
Public title Pharmacokinetic studies of curcumin-containing supplements in humans
Acronym Pharmacokinetic studies of curcumin-containing supplements in humans
Scientific Title Pharmacokinetic studies of curcumin-containing supplements in humans
Scientific Title:Acronym Pharmacokinetic studies of curcumin-containing supplements in humans
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the pharmacokinetic profile of curcumin-containing supplements.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma curcuminoids (curcumin, demethoxycurcumin, bisdemethoxycurcumin) concentration after a single ingestion of a curcumin-containing supplement.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Single intake of test supplement A
Interventions/Control_2 Single intake of test supplement B
Interventions/Control_3 Single intake of test supplement C
Interventions/Control_4 Single intake of test supplement D
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Japanese healthy males and females aged 20-65 years (age is the date of consent acquisition).
2) Subjects who weigh 50 kg or more for male and 45 kg or more for female.
3) Subjects who agree to participate in this study and can sign and date the consent document by themselves.
Key exclusion criteria 1) Subjects with disorders of central nervous system, cardio-vascular system, respiratory system, blood/hematopoietic function system, gastrointestinal system, liver/renal function, thyroid function, pituitary function, adrenal function, etc. or having a medical history of these disorders, and judged by the investigator to have safety concerns to conduct the study.
2) Subjects with a history of gastrointestinal symptoms or gastrointestinal resection that affect pharmacokinetics.
3) Subjects who are taking pharmaceuticals or undergoing therapy.
4) Subjects with drug allergies or history.
5) Subjects with allergic to curcumin-containing foods.
6) Subjects who have felt sick during blood donation and blood collection.
7) Subjects who have collected more than 400 mL of blood (such as blood donation) within the past 90 days starting from the scheduled administration date, or those who have collected more than 1200 mL of blood annually, including the blood collected in this study.
8) Subjects who cannot maintain abstinence and smoking cessation from 3 days before to the end of the study starting from the scheduled administration date.
9) Subjects who received other investigational drug within the past 90 days starting from the scheduled administration date.
10) Subjects who have taken supplements containing curcumin within the past 14 days starting from the scheduled administration date.
11) Subjects who have ingested curcumin-containing foods such as curry within the past 7 days starting from the scheduled administration date.
12) Employees of the implementing medical institution and employees of the study consignment organization.
13) Female subjects who wish to become pregnant during the study period, pregnant women (including possible) or breastfeeding.
14) In addition, subjects who are judged to be ineligible by the investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Teshima
Organization Lequio Pharma Co., Ltd.
Division name Research & Development Headquarters
Zip code 900-0036
Address 16-3, Nishi 2-chome, Naha, Okinawa 900-0036, Japan
TEL 098-867-9114
Email teshima@lequio-pha.co.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Teshima
Organization Lequio Pharma Co., Ltd.
Division name Research & Development Headquarters
Zip code 900-0036
Address 16-3, Nishi 2-chome, Naha, Okinawa 900-0036, Japan
TEL 098-867-9114
Homepage URL
Email teshima@lequio-pha.co.jp

Sponsor
Institute Lequio Pharma Co., Ltd.
Institute
Department

Funding Source
Organization Lequio Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Koizumi Dermatology Clinic
Address 27-1-41 Minami 1 Jonishi, Chuo-ku, Sapporo, Hokkaido
Tel 011-632-8484
Email info@mediks.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 12
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2021 Year 09 Month 15 Day
Date of IRB
2021 Year 09 Month 22 Day
Anticipated trial start date
2021 Year 09 Month 24 Day
Last follow-up date
2021 Year 10 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 10 Month 08 Day
Last modified on
2021 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052159

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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