UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052513 |
|---|---|
| Receipt number | R000059927 |
| Scientific Title | Effects of the test food on subjective symptoms |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2024/06/28 10:39:02 |
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Basic information
Public title
Effects of the test food on subjective symptoms
Acronym
Effects of the test food on subjective symptoms
Scientific Title
Effects of the test food on subjective symptoms
Scientific Title:Acronym
Effects of the test food on subjective symptoms
Region
| Japan |
Condition
Condition
Outclinic patient
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 8 weeks consumption of the test food on
subjective symptoms in adult women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective symptom questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 8 weeks
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) Female aged 18 years or older at the time of obtaining consent
(2) Make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
(1) Allergic to the ingredients of test food
(2) Taking dietary supplements that contain the ingredients of test food
(3)Known or suspected to be pregnant
(4) Previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood
(5) Participation in any clinical trial
(6) Judged as ineligible by the investigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Aoyagi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo
TEL
0368326013
hsrpd@rohto.co.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Shidomi |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Health Science Business Planning Division
Zip code
105-0022
Address
20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo
TEL
0368326013
Homepage URL
hsrpd@rohto.co.jp
Sponsor or person
Institute
ROHTO Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Rohto Pharmaceutical 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
Ethics Review Committee for Clinical Research, etc., Rohto Pharmaceutical Co.
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
Tel
06-6758-1231
rohtoirb@rohto.co.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
| 2023 | Year | 10 | Month | 18 | 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
263
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
| 2023 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059927
