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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026341
Receipt No. R000030258
Scientific Title A verification study of effective on quality of sleep: A randomized double-blind placebo-controlled crossover trial
Date of disclosure of the study information 2017/02/28
Last modified on 2018/05/11

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Basic information
Public title A verification study of effective on quality of sleep: A randomized double-blind placebo-controlled crossover trial
Acronym A verification study of effective on quality of sleep
Scientific Title A verification study of effective on quality of sleep: A randomized double-blind placebo-controlled crossover trial
Scientific Title:Acronym A verification study of effective on quality of sleep
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects on quality of sleep by taking test food
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. OSA sleep inventory MA version
*Fill it in immediately after waking up at home on the examination day and two days before
Key secondary outcomes 1. Sleep Scan
*Perform it at participant's home 1 week before each examination day

2. Uchida-Kreaepelin performance test
*Perform on each examination day

3. Questionnaires of subjective symptoms
a. Immediately on rising questionnaire
* Fill it in immediately after waking up at home on the examination day and two days before
b. Questionnaire when Uchida-Kreaepelin performance test
*Fill in the questionnaire before, after, and break Uchida-Kreaepelin performance test

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 1. Take the active capsule for 1 week
*Take 2 capsules with water or warm water 30 to 60 minutes before going to bed

2. After 1 week, take 2 active capsules with water or warm water 15 to 30 minutes before taking Uchida-Kreaepelin performance test

3. Washout for 1 week

4. Take the placebo capsule for 1 week
*Take 2 capsules with water or warm water 30 to 60 minutes before going to bed

5. After 1 week, take 2 placebo capsules with water or warm water 15 to 30 minutes before taking Uchida-Kreaepelin performance test
Interventions/Control_2 1. Take the placebo capsule for 1 week
*Take 2 capsules with water or warm water 30 to 60 minutes before going to bed

2. After 1 week, take 2 placebo capsules with water or warm water 15 to 30 minutes before taking Uchida-Kreaepelin performance test

3. Washout for 1 week

4. Take the active capsule for 1 week
*Take 2 capsules with water or warm water 30 to 60 minutes before going to bed

5. After 1 week, take 2 active capsules with water or warm water 15 to 30 minutes before taking Uchida-Kreaepelin performance test
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. Healthy Japanese adults who feel quality of sleep dissatisfaction

2. Within 1 and be employees

3. Those who are considered as appropriate for the study by the physician and are diagnosed insomnia

4. Within 3, those who have a relatively low score of OSA sleep inventory MA version at baseline
Key exclusion criteria 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome or other chronic diseases

3. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily

4. Currently taking medicines and/or herbal medicines

5. Those who are allergic to medicines and/or the test food related products

6. Those who are pregnant, breast-feeding, and plan to become a pregnant

7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial

8. Those who live with infants (less than 1-year-old)

9. Those who sleep with children (1 to 6 years old)

10. Those who live with requiring long-term care persons

11. Those who sleep with more than one person in a bed

12. Those who work late-night shift and the life-styles are irregular

13. Body mass index (BMI) is more than 25 kg/m2

14. A frequency of urination is more than 8 times per day

15. Those who are susceptible to pollen allergy or are suffering from asthma

16. Those who have diarrhea with dairy products (including those diagnosed with lactose intolerance)

17. Others considered as inappropriate for the study by the physician
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Email kazu@orthomedico.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko SUZUKI
Organization ORTHOMEDICO Inc.
Division name R&D Department
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization TOKIWA PHYTOCHEMICAL CO., LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Nakata A, Yamashita S, Suzuki N, Liang T, Kuniyoshi T, Yang J, Takara T. Effect of an Apocynum venetum  leaf extract (VENETRON (R) ) on sleep quality and psychological stress improvement -A randomized, double-blind, placebo-controlled crossover study-. Jpn Pharmacol Ther 2018; 46(1): 117-125.
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 Completed
Date of protocol fixation
2017 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 28 Day
Last modified on
2018 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030258

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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