UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026468 |
|---|---|
| Receipt number | R000030373 |
| Scientific Title | Evaluation of the effect of placental extract powder on sleep quality of healthy volunteers not satisfying their sleep |
| Date of disclosure of the study information | 2017/03/13 |
| Last modified on | 2020/10/23 14:59:02 |
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Basic information
Public title
Evaluation of the effect of placental extract powder on sleep quality of healthy volunteers not satisfying their sleep
Acronym
Effect of placental extract on sleep
Scientific Title
Evaluation of the effect of placental extract powder on sleep quality of healthy volunteers not satisfying their sleep
Scientific Title:Acronym
Effect of placental extract on sleep
Region
| Japan |
Condition
Condition
Sleep quality (non-diseased state)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of placental extract powder in healthy volunteers not satisfying their sleep.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of deep sleep
Key secondary outcomes
Sleep duration, The St. Mary's Hospital sleep questionnaire, safety
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of placental extract-containing food (placental extract powder 300 mg/day for 2 weeks) -> No sample intake (2 weeks) -> Oral intake of placebo (2 weeks)
Interventions/Control_2
Oral intake of placebo (for 2 weeks) -> No sample intake -> Oral intake of placental extract-containing food (placental extract powder 300 mg/day for 2 weeks)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects not satisfying their sleep quality but not in diseased state.
2) Agree to participate in the study and afford written informed consent.
Key exclusion criteria
1) Pregnant or possibly pregnant.
2) Diagnosed as sleep disorder.
3) Having medical cares for sleep disorder (e.g., hypnotic).
4) Using drugs/foods (e.g., alcohol) affecting sleep.
5) Using placental extract-containing drugs
6) Score of Pittsburgh Sleep Quality Index <= 5 or >= 11
7) Not agree to afford written informed consent.
8) Inappropriate as subjects by the decision of doctor in attendance.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mahiko |
| Middle name | |
| Last name | Nagase |
Organization
Kichijoji Traditional Chinese Medicine Clinic
Division name
Director
Zip code
180-0004
Address
1-13-6 Kichijoji, Musashino-shi, Tokyo 180-0004, Japan
TEL
0422-20-4110
mahiko@kca.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Ohishi |
Organization
Snowden Co., Ltd.
Division name
Healthcare Marketing and Sales Div.
Zip code
101-0032
Address
3-7-16 Iwamotocho, Chiyoda-ku, Tokyo 101-0032, Japan
TEL
03-3866-2828
Homepage URL
m_ohishi@snowden.co.jp
Sponsor or person
Institute
Japan Society of Clinical Placenta Medicine
Institute
Department
Personal name
Funding Source
Organization
Snowden Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Japan Society of Clinical Placenta Medicine
Address
6-4-5-1104 Tsukiji, Chuo-ku, Tokyo 204-0045, Japan
Tel
03-6264-2991
jplacenta@yahoo.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 13 | Day |
Related information
URL releasing protocol
https://doi.org/10.3389/fnut.2020.550287
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.3389/fnut.2020.550287
Number of participants that the trial has enrolled
32
Results
No effect of PPE on the sleep length was observed. Several measures
in the subjective St. Mary's Hospital Sleep Questionnaire, i.e., changes in Q5 (sleep
depth) and Q9 (sleep wellness) between pre- and post-ingestions, were significantly
different between groups in the direction of improvement of subjective sleep quality in
the PPE group.
Results date posted
| 2020 | Year | 10 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 20 | Day |
Baseline Characteristics
Placebo-first: Age (34-52, Gender (female 8, male 0), Pittsburgh Sleep Quality Index total score (7-10.
PPE-first: Age (28-73, gender (female 1, male 1), Pittsburgh Sleep Quality Index total score (6-10.
Total: Age (28-73, gender (female 19, male 1), Pittsburgh Sleep Quality Index total score (6-10.
Participant flow
Randomization: 32 (16 vs. 16 for placebo first and PPE first, respectively)
Placebo first group: exclusion n=5; decline n=3
PPE first group: exclusion n = 1, decline n=3
Finally analyzed: n=8 and 12 for placebo first and PPE first groups, respectively.
Adverse events
None
Outcome measures
Objective sleep depth was not significantly different between groups.
Some aspects of subjective sleep quality were significantly (p<0.05) improved by PPE (Sleep depth (-0.45 vs. 1.15) and Sleep wellness (-0.15 vs. 1.15)).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030373
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