UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055022 |
|---|---|
| Receipt number | R000062849 |
| Scientific Title | Effects of consumption of the test food on premenstrual unidentified complaints: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/07/19 |
| Last modified on | 2024/07/19 11:02:18 |
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Basic information
Public title
Effects of consumption of the test food on premenstrual unidentified complaints
Acronym
Effects of consumption of the test food on premenstrual unidentified complaints
Scientific Title
Effects of consumption of the test food on premenstrual unidentified complaints: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on premenstrual unidentified complaints
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of continuous consumption for eight weeks of the test food on premenstrual complaints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the 2nd examination after consumption (2nd)
Key secondary outcomes
1. The amount and rate of change of Neg Affect in the MDQ (before menstruation) from screening (before consumption; Scr) at 2nd
2. The measured value of Neg Affect in the MDQ (during and after menstruation) at 2nd, and the amount and rate of changes of them from Scr
3. The measured values of Pain, Water Reten, Auto React, Impair Conc, Behave Change, Arousal, Control, and each item in the MDQ (before, during and after menstruation) at 2nd, and the amount and rate of changes of them from Scr
4. The measured values of Pain, Water Reten, Auto React, Neg Affect, Impair Conc, Behave Change, Arousal, Control, and each item in the MDQ (before, during and after menstruation) at the 1st examination after consumption (1st), and the amount and rate of changes of them from Scr
5. The measured values of transepidermal water loss (TEWL) and the moisture content of skin surface at 1st and 2nd, and the amount and rate of changes of them from Scr
6. The measured values of subjective Premenstrual Syndrome (PMS) symptoms measured by visual analog scale (VAS) at 1st and 2nd, and the amount and rate of change of them from Scr
7. The measured values of estradiol, progesterone, follicle-stimulating hormone, and luteinizing hormone at 1st and 2nd, and the amount and rate of changes of them from Scr
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: Approximately eight weeks (Two cycles of menstruation: 50 days~76 days)
Test food: Active food
Interventions/Control_2
Duration: Approximately eight weeks (Two cycles of menstruation: 50 days~76 days)
Test food: Placebo food
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. Japanese
2. Women
3. Adults
4. Healthy individuals
5. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDI)-II at Scr
6. Individuals whose menstrual cycle is between 25 and 38 days
7. Individuals whose lasting period of the menstruation is between 3 and 7 days
8. Individuals whose score of Neg Affect in the MDQ (before menstruation) is high at Scr
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are undergoing medical treatment or have a medical history of gynecological disease {such as premenstrual syndrome (PMS), premenstrual dysphoric Disorder (PMDD), secondary amenorrhea, dysmenorrhea, endometriosis, hysteromyoma, breast cancer, cervical cancer, endometrial cancer, or ovarian cancer}
5. Individuals who are undergoing medical treatment or have a medical history of immune system disease such as multiple sclerosis, lupus erythematosus, or any other autoimmune diseases
6. Individuals who have severe menstrual pain that cannot be controlled with analgesics
7. Individuals who are undergoing medical treatment or have a medical history of psychiatric disorder
8. Individuals who receive hormonal therapy
9. Individuals who are taking low-dose oral contraceptives regularly
10. Postmenopausal individuals
11. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
12. Individuals who are taking or using medications (including herbal medicines) and supplements
13. Individuals who are allergic to medicines or foods related to the test products
14. Individuals who are pregnant, lactating, or planning to become pregnant during this study
15. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
16. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
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
Toyo Sugar Refining Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association Minami-machi 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 Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062849
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