UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049908 |
|---|---|
| Receipt number | R000056844 |
| Scientific Title | Safety evaluation in an open-label study of an overdose of the capsules containing Valeriana fauriei root (VF) extract. |
| Date of disclosure of the study information | 2022/12/27 |
| Last modified on | 2022/12/26 17:31:56 |
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Basic information
Public title
Safety evaluation of the capsules containing Valeriana fauriei root (VF) extract.
Acronym
Safety evaluation of the capsules containing VF extract.
Scientific Title
Safety evaluation in an open-label study of an overdose of the capsules containing Valeriana fauriei root (VF) extract.
Scientific Title:Acronym
Safety evaluation of the capsules containing VF extract.
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the safety of taking capsules containing VF extract on sleep.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse effects: number and incidence of adverse effects.
Key secondary outcomes
1. Adverse effects: number and incidence of adverse effects.
2. Blood pressure/pulse rate.
3. Trends in hematology, blood biochemistry and urinalysis.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration:4 weeks
Trial food: Soft capsule containing VF extract (1 g/1 capsule)
Dosage and administration: Take 10 capsules (equivalent to 10 g of VF extract) with water 30 minutes before bedtime.
Interventions/Control_2
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 written consent to take part in the trial.
2. Men or women aged 20 to 65.
3. Subjects with ability to take 10 capsules daily.
4. 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. Women having the possibility or intention to become pregnant, lactating
Target sample size
10
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
467-8601
Address
1 Kawazumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-7215
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 | 12 | Month | 27 | 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
| 2023 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 13 | 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 | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056844
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
