Unique ID issued by UMIN | UMIN000018317 |
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Receipt number | R000021172 |
Scientific Title | Evaluation of the effect of placental extract powder to improve health condition of climacteric women |
Date of disclosure of the study information | 2015/07/16 |
Last modified on | 2017/03/07 15:50:12 |
Evaluation of the effect of placental extract powder to improve health condition of climacteric women
Effect of placental extract on climacteric women
Evaluation of the effect of placental extract powder to improve health condition of climacteric women
Effect of placental extract on climacteric women
Japan |
Health condition of climacteric women (non-diseased state)
Obstetrics and Gynecology | Adult |
Others
NO
To investigate the efficacy and safety of dietary supplement containing placental extract powder in climacteric women
Safety,Efficacy
Simplified Menopausal Index (SMI)
serum estradiol (E2), serum follicle-stimulating hormone (FSH), safety
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is considered as a block.
YES
Numbered container method
2
Treatment
Food |
Oral intake of placental extract-containing food (placental extract powder 300 mg/day for 12 weeks); n=20
Oral intake of placebo (for 12 weeks); n=20
45 | years-old | <= |
60 | years-old | > |
Female
(Subjects fulfilling all of the following criteria)
1) Climacteric women, who feels bad health, though are not in diseased state.
2) Agree to participate in the study and afford written informed consent.
(Subjects fulfilling at least one of the following criteria)
1) Pregnant or possibly pregnant.
2) Diagnosed as menopausal symptoms.
3) Using female hormone drugs.
4) Using drugs affecting female hormone state.
5) Using placental extract-containing drugs
6) SMI > 50
6) Lower serum E2 level (<=10 pg/mL) and higher serum FDH level (>=40 IU/mL).
7) Not agree to afford written informed consent.
8) Inappropriate as subjects by the decision of doctor in attendance.
40
1st name | |
Middle name | |
Last name | Mahiko Nagase |
Kichijoji Traditional Chinese Medicine Clinic
Director
1-13-6 Kichijoji, Musashino-shi, Tokyo 180-0004, Japan
0422-20-4110
mahiko@kca.biglobe.ne.jp
1st name | |
Middle name | |
Last name | Masami Ohishi |
Snowden Co., Ltd.
Academic Support Dept. Healthcare Marketing and Sales Div.
3-7-16 Iwamotocho, Chiyoda-ku, Tokyo 101-0032, Japan
03-3866-2828
m_ohishi@snowden.co.jp
Japan Society of Clinical Placenta Medicine
Snowden Co., Ltd.
Profit organization
Japan
NO
2015 | Year | 07 | Month | 16 | Day |
Published
https://doi.org/10.1080/13697137.2017.1279140
(1) The total SMI score of the PPE group was significantly more improved after 12 weeks than that of the placebo group (p = 0.031).
(2) This score and three subscores (vasomotor, psychological, and somatic symptoms) were significantly improved at 8 and/or 12 weeks compared with the initial values in the PPE group (p<0.05). (3) E2 and FSH levels were not improved in either group.
(4) No adverse events were observed.
Main results already published
2015 | Year | 07 | Month | 07 | Day |
2015 | Year | 07 | Month | 17 | Day |
2016 | Year | 03 | Month | 02 | Day |
2016 | Year | 09 | Month | 26 | Day |
2015 | Year | 07 | Month | 15 | Day |
2017 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021172
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