UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

TOKIWA PHYTOCHEMICAL CO., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2017

Year

02

Month

28

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2017

Year

02

Month

28

Day

Last modified on

2018

Year

05

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030258