Unique ID issued by UMIN | UMIN000037409 |
---|---|
Receipt number | R000042643 |
Scientific Title | Effect of the supplement on edma of the lower limbs in healthy females - A randomized controlled trial - |
Date of disclosure of the study information | 2019/07/22 |
Last modified on | 2020/03/26 12:13:42 |
Effect of the supplement on edma of the lower limbs in healthy females
- A randomized controlled trial -
Effect of the supplement on edma of the lower limbs in healthy females
Effect of the supplement on edma of the lower limbs in healthy females
- A randomized controlled trial -
Effect of the supplement on edma of the lower limbs in healthy females
Japan |
Healthy subjects
Adult |
Others
NO
To investigate the effect of supplement on edma of the lower limbs in healthy females aged between 20 and 40 years old.
Safety,Efficacy
Questionnaire for the edma of lower limbs
Adverse event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
3
Treatment
Food |
Test food A: 8 tablets/day for 1 week
Test food B: 2 tablets/day for 1 week
Test food C: 1 tablets/day for 1 week
20 | years-old | <= |
40 | years-old | > |
Female
1)Healthy Japanese females aged 20 to 40 years of age at the time of the informed consent.
2)Subject with systolic blood pressure less than 130 mmHg at SCR.
3)Subject who is currently aware of the edema of lower limbs.
4)Subject who has understood the purpose of the study,and agreed to participate by signing the written informed consent.
1)Subject with BMI <= 18.5 kg/m2 and >30 kg/m2.
2)Subject who is taking medication or who is currently under medical treatment.
3)Subject who is under exercise therapy or dietetic therapy.
4)Subject who has an allergy for test food (especially milk allergy) .
5)Subject who has or had a history of either medicine or alcohol dependence syndrome.
6)Subject who has or had a history of mental illness (depression) or sleep disturbance.
7)Subject whose lifestyle is extremely irregular.
8)Subject who has an unbalanced diet.
9)Subject who has serious illness or history such as immune disease, brain disease, malignant tumor, diabetes, liver disease (hepatitis), kidney disease or heart disease, thyroid disease, adrenal disease or other metabolic disease.
10)Subject who cannot stop using the health foods, supplements and medicines that may affect edema and fatigue of lower limbs such as Melilotus extract, long pepper extract, BCAA (branched chain amino acid) during the test period.
11)Subject who cannot stop using products to treat the edema of the lower limbs (pressure socks or stockings, and other tings alike) during the study period.
12)Subject who cannot stop taking food and drinks that is specified as health food or food with functional claims, that may affect the edma of the lower limbs during the study period.
13)Subject who cannot stop taking other medications (including Chinese medicine) or supplements during the study period.
14)Subject who has participated in other clinical studies within the last 3 months or is planning to participate in other clinical studies during the study period.
15)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
16)Subject who cannot keep the daily records.
17)Subject who is considered as an inappropriate candidate by the doctor in charge.
102
1st name | Kei |
Middle name | |
Last name | Yui |
FANCL Corporation
Research Institute, Health Science Research Center
244-0806
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
045-820-3510
ke-yui@fancl.co.jp
1st name | Daisuke |
Middle name | |
Last name | Ochitani |
HUMA R&D CORP
Clinical Development Division
108-0014
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
03-3431-1260
ochitani@huma-rd.co.jp
HUMA R&D CORP
FANCL Corporation
Profit organization
Ethics Committees of Nihonbashi Egawa Clinic
2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
03-5204-0311
jim@medipharma.co.jp
NO
2019 | Year | 07 | Month | 22 | Day |
Unpublished
102
Completed
2019 | Year | 06 | Month | 20 | Day |
2019 | Year | 07 | Month | 12 | Day |
2019 | Year | 07 | Month | 31 | Day |
2019 | Year | 09 | Month | 06 | Day |
2019 | Year | 09 | Month | 09 | Day |
2019 | Year | 09 | Month | 17 | Day |
2020 | Year | 03 | Month | 19 | Day |
2019 | Year | 07 | Month | 18 | Day |
2020 | Year | 03 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042643