UMIN ID: UMIN000055400
Registered date:14/09/2024
Efficacy of plant extracts on sleep quality
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Not applicable |
| Date of first enrollment | 2024/09/17 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Ingestion of plant extract for 12 days Ingestion of placebo for 12 days |
Outcome(s)
| Primary Outcome | Visual analogue scale (VAS) for fatigue, when waking up. |
|---|---|
| Secondary Outcome | VAS for sleep quality VAS for fatigue OSA sleep inventory Fatigue scale POMS2 |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male |
| Include criteria | |
| Exclude criteria | 1.Patient 2.BMI>28kg/m2 3.Hypertension 4.Inaccurate evaluation of VSA 5.Alcohol abuse 6.Short sleeper 7.Use of sleep medication 8.Irregular sleep patterns 9.Participants of other clinical trials 10.Food allergy |
Related Information
| Primary Sponsor | Kyowa trial Corporation |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kao Corporation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Isao Takehara |
| Address | 1-16,kita 11-jo,nishi 14-chome,chuo-ku,Sapporo-shi,Hokkaido 060-0011 |
| Telephone | +81-11-200-9431 |
| i-takehara@kyowa-t.com | |
| Affiliation | Kyowa trial Corporation Clinical research department. |
| scientific contact | |
| Name | Takeshi Kanaya |
| Address | 1-16,kita 11-jo,nishi 14-chome,chuo-ku,Sapporo-shi,Hokkaido |
| Telephone | +81-11-757-3387 |
| y-kohzai@kyowa-t.com | |
| Affiliation | Yamazaki Otolaryngology Clinic chief director |