UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057886 |
|---|---|
| Receipt number | R000066055 |
| Scientific Title | Systematic Review on the Functional Benefits of Sleep Quality Improvement by Functional Ingredients "Hyperoside Derived from Apocynum venetum" and "Isoquercitrin Derived from Apocynum venetum" |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/05/08 16:06:15 |
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Basic information
Public title
Systematic Review on the Functional Benefits of Sleep Quality Improvement by Functional Ingredients "Hyperoside Derived from Apocynum venetum" and "Isoquercitrin Derived from Apocynum venetum"
Acronym
Systematic Review on the Improvement of Sleep Quality by "Hyperoside Derived from Apocynum venetum" and "Isoquercitrin Derived from Apocynum venetum"
Scientific Title
Systematic Review on the Functional Benefits of Sleep Quality Improvement by Functional Ingredients "Hyperoside Derived from Apocynum venetum" and "Isoquercitrin Derived from Apocynum venetum"
Scientific Title:Acronym
Systematic Review on the Improvement of Sleep Quality by "Hyperoside Derived from Apocynum venetum" and "Isoquercitrin Derived from Apocynum venetum"
Region
| Japan |
Condition
Condition
healthy adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate whether the intake of Hyperoside and Isoquercitrin derived from Apocynum venetum improves sleep quality compared to placebo intake in healthy adult men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep state measured by brain waves (such as the duration of REM sleep and non-REM sleep), subjective evaluation (questionnaires such as OSA-MA,VAS)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants P:"Healthy adult men and women." Excludes individuals with diseases, minors, pregnant women, and breastfeeding women.
Intervention I: "Oral intake of processed foods containing Hyperoside and Isoquercitrin derived from Apocynum venetum." Excludes cases where the amount of Hyperoside and Isoquercitrin derived from Apocynum venetum is not specified.
Placebo C: "Oral intake of processed foods not containing Hyperoside and Isoquercitrin derived from Apocynum venetum." Excludes cases where the processed foods contain Hyperoside, Isoquercitrin, or other ingredients that clearly affect the outcomes.
Outcome O: "Whether sleep quality improves." Objective evaluation includes sleep state measured by brain waves (such as the duration of REM sleep and non-REM sleep). Subjective evaluation includes questionnaires such as OSA-MA and VAS.
Key exclusion criteria
Exclude trials that do not meet the selection criteria, such as those including individuals with diseases.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Takeuchi |
Organization
Association of Japan CAM
Division name
N/A
Zip code
151-0053
Address
#306 Onogibiru,3-46-16 Yoyogi, Shibuya-ku, Tokyo
TEL
03-6457-4911
info@ajcam.biz
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Japan Clinical Trial Association
Division name
N/A
Zip code
1600022
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL
0364574666
Homepage URL
info@yakujihou.org
Sponsor or person
Institute
Japan Clinical Trial Association
Institute
Department
Personal name
Funding Source
Organization
NAIA Corporation
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
Japan Clinical Trial Association
Address
5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel
0364574666
info@yakujihou.org
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
| 2025 | Year | 05 | Month | 26 | 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
| 2025 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search Strategy
For database searches in PubMed, JDream3, UMIN, and ClinicalTrials.gov, reviewers A and B will discuss and set the search formulas corresponding to the research question and PICOS. The search formulas will combine thesaurus terms and free words in the databases. For the trial design filter, the "sensitivity and precision-maximizing version" from the Cochrane library will be used. Additionally, using the Consumer Affairs Agency's notification information search, studies adopted in the research review will be extracted from cases where Hyperoside and Isoquercitrin derived from Apocynum venetum were applied as functional ingredients.
Bias Risk Assessment
Evaluate selection bias (randomization, allocation concealment), blinding bias (participants, outcome assessors), attrition bias (analysis methods, incomplete outcome data), selective outcome reporting, other biases, summary, and non-directness of individual studies. Assess the risk as "high," "medium/suspected," or "low."
Certainty Assessment
Evaluate the risk of bias, indirectness, imprecision, inconsistency, and other factors (such as publication bias) for each outcome. Finally, these evaluations will be combined to assess the overall certainty of the evidence. The risk of bias, indirectness, imprecision, inconsistency, and other factors (such as publication bias) will be assessed in three levels: not serious, serious, and very serious. Certainty will be graded in four levels: A (strong), B (moderate), C (weak), and D (very weak).
Management information
Registered date
| 2025 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066055
