UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031429
Receipt No. R000035887
Scientific Title Evaluation of effectiveness of psyllium-containing food
Date of disclosure of the study information 2018/02/23
Last modified on 2018/08/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of effectiveness of psyllium-containing food
Acronym Evaluation of effectiveness of psyllium-containing food
Scientific Title Evaluation of effectiveness of psyllium-containing food
Scientific Title:Acronym Evaluation of effectiveness of psyllium-containing food
Region
Japan

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

Objectives
Narrative objectives1 We conduct clinical trials for people with smoking habits.
Evaluate the effect on smoking when foods containing plant extracts are ingested continuously.
Evaluate placebo as a control.
Evaluate placebo as a control.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Compare with the "smoking number" per day before ingesting food and after ingesting 4 weeks
Key secondary outcomes subjective evaluation, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of food containing plant extract for 4 consecutive weeks
Interventions/Control_2 Ingestion of placebo for 4 consecutive weeks
Interventions/Control_3
Interventions/Control_4
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
69 years-old >=
Gender Male and Female
Key inclusion criteria 1. Males and females between 20 and 69 years of age inclusive
2. The smoking number of one day is a person of more than 11 cigarettes.
Key exclusion criteria 1. The person smoking only by the "heated tobacco products"
2. Subjects who are pregnant or lactating
3. Subjects who consume medicinal product which may influence the study
4. Subjects who consume food which may influence the study
5. Subjects who are judged as unsuitable for the study by the principal investigator for the other reason
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatomo Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email jacta@usjri.com

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization AINOA Inc.
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
Address
Tel
Email

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
2018 Year 02 Month 23 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
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 Completed
Date of protocol fixation
2018 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 22 Day
Last modified on
2018 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035887

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.