Unique ID issued by UMIN | UMIN000048625 |
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Receipt number | R000055400 |
Scientific Title | Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function |
Date of disclosure of the study information | 2022/08/08 |
Last modified on | 2022/12/26 14:42:18 |
Clinical trials on the efficacy and safety of Shikuwasa seed extract extracted from Shikuwasa seed for motor function
Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function
Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function
Clinical trials on the efficacy and safety of Shikuwasa seed extract for motor function
Japan |
Decline in motor function with aging
Adult |
Others
NO
Verification of the safety and efficacy of Shikuwasa seed extract for motor function and anti-obesity
Safety,Efficacy
6-minute walking test
BMI, body fat percentage, grip strength measurement, chair standing test, HbA1c
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
The test product is No. 2 hard capsule (made of hydroxypropyl methylcellulose) containing 160 mg of Shikuwasa seed extract (containing 65% nomilin and 25% limonin).
The 50 subjects will be divided into a test product group (25 patients) and a placebo group (25 patients), and the distribution will be randomized and double-blind. Ingestion is 2 capsules once daily for 12 weeks in the morning.
placebo is No. 2 hard capsule containing dextrin.
65 | years-old | <= |
90 | years-old | >= |
Female
Women over the age of 65 who are basically healthy but feel some decline in motor function with age.
1.Those who are being treated for motor dysfunction or taking supplements thereof
2.Those within half a year after the end of treatment for motor dysfunction
3.Those with disabilities in the limbs
4.Those who need long-term care to stand up or walk
5.Things that are difficult to communicate
6.Others that the attending physician deems inappropriate for registration in this study
50
1st name | Kimio |
Middle name | |
Last name | Sugaya |
Southern Nights' Laboratory Co., Ltd.
CEO
904-0113
1-1-823 Miyagi, Chatan, Okinawa
09049987459
sugaya@sklabo.co.jp
1st name | Kimio |
Middle name | |
Last name | Sugaya |
Southern Knights' Laboratory Co., Ltd.
CEO
904-0113
1-1-823 Miyagi, Chatan, Okinawa
09049987459
sugaya@sklabo.co.jp
Southern Nights' Laboratory Co., Ltd.
Okinawa Prefecture
Local Government
NatuPharma Ryukyus, Co., Ltd.
Kawahara Urology Ethics Review Board
73-3 Nishimotida, Aira, Kagoshima
0995-64-5181
yamashita.hami@kawahara.or.jp
NO
2022 | Year | 08 | Month | 08 | Day |
Unpublished
Completed
2022 | Year | 07 | Month | 06 | Day |
2022 | Year | 07 | Month | 27 | Day |
2022 | Year | 08 | Month | 21 | Day |
2022 | Year | 12 | Month | 26 | Day |
2022 | Year | 08 | Month | 08 | Day |
2022 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055400
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