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 |
Effects of consumption of the test food on premenstrual unidentified complaints
Effects of consumption of the test food on premenstrual unidentified complaints
Effects of consumption of the test food on premenstrual unidentified complaints: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on premenstrual unidentified complaints
Japan |
Healthy Japanese
Not applicable | Adult |
Others
NO
To verify the effects of continuous consumption for eight weeks of the test food on premenstrual complaints.
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The measured value of Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the 2nd examination after consumption (2nd)
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Educational,Counseling,Training
Food |
Duration: Approximately eight weeks (Two cycles of menstruation: 50 days~76 days)
Test food: Active food
Duration: Approximately eight weeks (Two cycles of menstruation: 50 days~76 days)
Test food: Placebo food
18 | years-old | <= |
Not applicable |
Female
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
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
60
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
1st name | Naoko |
Middle name | |
Last name | Suzuki |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Toyo Sugar Refining Co., Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association Minami-machi Clinic
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
IRB@takara-clinic.com
NO
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)
2024 | Year | 07 | Month | 19 | Day |
Unpublished
Open public recruiting
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 06 | Month | 24 | Day |
2024 | Year | 07 | Month | 19 | Day |
2024 | Year | 12 | Month | 28 | Day |
2024 | Year | 07 | Month | 19 | Day |
2024 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062849
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |