UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033475 |
|---|---|
| Receipt number | R000038171 |
| Scientific Title | A study of QOL of plant-abstraction extract in female. - pilot study - |
| Date of disclosure of the study information | 2019/10/30 |
| Last modified on | 2020/09/15 09:30:29 |
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Basic information
Public title
A study of QOL of plant-abstraction extract in female. - pilot study -
Acronym
A study of QOL of plant-abstraction extract in female. - pilot study -
Scientific Title
A study of QOL of plant-abstraction extract in female. - pilot study -
Scientific Title:Acronym
A study of QOL of plant-abstraction extract in female. - pilot study -
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the QOL of plant-abstraction extract in female.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
intake low-dose food of plant-abstraction extract, twice per day for 8 weeks
Interventions/Control_2
intake high-dose food of plant-abstraction extract, twice per day for 8 weeks
Interventions/Control_3
Intake placebo-controlled food twice per day for 8 weeks
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Females aged from 20 to 69 years old.
Key exclusion criteria
1) Subjects who have the habit of taking test food.
2) Subjects who have the habit of taking healthcare products.
3) Subjects who have a habit of binge drinking.
4) Patients who have serious disease or subjects who have serious disease history.
5) Subjects who take warfarin potassium or antacid.
6) Subjects who has allergies to plants.
7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
8) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period.
9) Subjects who are participated in other clinical studies.
10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
11) Subjects who are judged unfit to enroll in this trial by the investigator.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Ueda |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Central R&D Laboratory
Zip code
Address
1-30-3, Toyokawa, Ibaraki-ciy, OSAKA, 567-0057 JAPAN
TEL
090-8510-4389
t.ueda@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Tajima |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Central R&D Laboratory
Zip code
Address
1-30-3, Toyokawa, Ibaraki-ciy, OSAKA, 567-0057 JAPAN
TEL
080-3465-1852
Homepage URL
s.tajima@kobayashi.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 10 | Month | 30 | 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 | 07 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038171
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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