UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048811 |
|---|---|
| Receipt number | R000055620 |
| Scientific Title | A randomized, double-blind, placebo-controlled, crossover comparative study of evaluation of sleep-improvement effects of the capsules containing Valeriana fauriei root (VF) extract |
| Date of disclosure of the study information | 2022/09/04 |
| Last modified on | 2022/08/31 23:53:29 |
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Basic information
Public title
Evaluation of sleep-improvement effects of the capsules containing Valeriana fauriei root (VF) extract
Acronym
Evaluation of sleep-improvement effects of the capsules containing VF extract
Scientific Title
A randomized, double-blind, placebo-controlled, crossover comparative study of evaluation of sleep-improvement effects of the capsules containing Valeriana fauriei root (VF) extract
Scientific Title:Acronym
Evaluation of sleep-improvement effects of the capsules containing VF extract
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of taking capsules containing VF extract on sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of sleep quality based on the Obstructive sleep apnea syndrome (OSA) Sleep Questionnaire.
Key secondary outcomes
Evaluation of sleep quality using the OSA Sleep Questionnaire for each sleep complaint on the Athens Insomnia Scale (AIS).
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 2 weeks
Trial food: Soft capsule containing VF extract (1 g/1 capsule)
Dosage and administration: Take 2 capsules (equivalent to 2 g of VF extract) with water 30 minutes before bedtime.
Interventions/Control_2
Duration: 2 weeks
Trial food: Placebo soft capsule (Same form as the VF capsule, with the same odor)
Dosage and administration: Take 2 capsules with water 30 minutes before bedtime.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects with sleep problems.
2. Subjects with an AIS score of 6 or higher.
3. Subjects with written consent to take part in the trial.
4. Men or women aged 20 to 65.
5. Subjects with an easy intake of capsules.
6. Subjects who can complete the questionnaire via smartphone, tablet, or computer.
Key exclusion criteria
1. Subjects currently being treated for severe renal or liver disease, heart, respiratory or endocrine disease, or other metabolic diseases.
2. Subjects currently taking medications that interfere with sleep (sleeping pills, antianxiety drugs)
3. Subjects allergic to gelatin.
4. Subjects work irregular/night/early morning shifts every day.
5. Women having the possibility or intention to become pregnant, lactating
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Nojiri |
Organization
Nagoya City University Hospital
Division name
East-Asian traditional medicine center
Zip code
4678601
Address
1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
+81528538211
snojiri@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Misato |
| Middle name | |
| Last name | Ota |
Organization
Kuki Sangyo Co., Ltd.
Division name
R&D Medicinal Department
Zip code
510-0059
Address
11 Onoe-cho, Yokkaichi-shi, Mie, Japan.
TEL
059-350-2050
Homepage URL
m_oota@kuki-info.co.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kuki Sangyo Co., Ltd.
R&D Medicinal Department
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Office, Clinical Research Development Support Center, Nagoya City University Hospital
Address
1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
Tel
052-853-8348
irb_jimu@med.nagoya-cu.ac.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
| 2022 | Year | 09 | Month | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2022 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055620
