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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026468
Receipt No. 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 2019/03/11

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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
Email 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
Email m_ohishi@snowden.co.jp

Sponsor
Institute Japan Society of Clinical Placenta Medicine
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 32
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030373

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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