UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033445 |
|---|---|
| Receipt number | R000038133 |
| Scientific Title | A verification study for improving unidentified complaints with the test food before and after menstruation: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2018/07/19 |
| Last modified on | 2019/03/31 13:53:04 |
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Basic information
Public title
A verification study for improving unidentified complaints with the test food before and after menstruation: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym
A verification study for improving unidentified complaints with the test food before and after menstruation
Scientific Title
A verification study for improving unidentified complaints with the test food before and after menstruation: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
A verification study for improving unidentified complaints with the test food before and after menstruation
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the unidentified complaints alleviation with the test food before and after menstruation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The Japanese version of the menstruation distress questionnaire (MDQ)
* Assess the QOL before, during, and after menstruation
* Compare the measured values between screening (before consumption) and 4 and 8 weeks after consumption
Key secondary outcomes
1. SF-36 (Medical Outcomes Study Short-Form 36-Item Health Survey)
2. Questionnaire about symptoms during menstruation (Visual Analogue Scale)
3. Bust measurements (top and under)
4. Measure the height from the ground to top of the bust
5. Hip measurement
6. Waist measurement
7. Serum progesterone level
8. Serum estradiol level
*1-8 Compare the measured values between screening (before consumption) and 4 and 8 weeks after consumption
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 8 weeks
Test material: Active capsule
Dose: One capsule per day
Administration: Take a capsule with water or warm water after breakfast
* If you forget to take the capsule, take it as soon as you remember within the day.
Interventions/Control_2
Duration: 8 weeks
Test material: Placebo capsule
Dose: One capsule per day
Administration: Take a capsule with water or warm water after breakfast
* If you forget to take the capsule, take it as soon as you remember within the day.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Healthy Japanese female with experiencing unidentified complaints before and during menstruation
2. Subjects who are judged as eligible to participate in the study by the physician
3. Within the subjects who met the 1st and 2nd inclusion criteria, subjects whose total scores in the MDQ are relatively high at screening (before consumption)
Key exclusion criteria
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
3. Subjects who are diagnosed with premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD)
4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily
5. Subjects who are currently taking medications (including herbal medicines and the pill) and supplements
6. Subjects who experience menopause
7. Subjects who are allergic to medicines and/or the test food related products
8. Subjects who are pregnant, lactation, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
11. Subjects who receive counseling or psychological therapy
12. Subjects who receive hormonal therapy
13. Subjects who suffer from mental disorders or have a medical history of mental disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | YAMAMOTO |
Organization
ORTHOMEDICO Inc.
Division name
CEO
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
kazu@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | SUZUKI |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Oryza Oil&Fat Chemical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
info@takara-clinic.com
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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 19 | 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
44
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 | 09 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | 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 | 19 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038133
