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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033445
Receipt No. 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

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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
Email 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
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038133

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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