The verification study for health-related quality of life improvement effects: a randomized double-blind, parallel-group, placebo-controlled study

The verification study for health-related quality of life improvement effects: a randomized double-blind, parallel-group, placebo-controlled study - The verification study for health-related quality of life improvement effects for health

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028622

Enrollment

Registered

2017-08-10

Start date

2017-08-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese adults

Interventions

Duration: 12 weeks Test materials: Passionflower extract-P Dose: Take a capsule once a day Administration: Take a capsule during an hour before going to bed Duration: 12 weeks Test materials: Plac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adults 2. Subjects who tend to be disturbed their life rhythm, or to be unmotivated and not to concentrate on their jobs or housework 3. Subjects who are judged as eligible to participate in the study by the principal investigator 4. Subjects who have relatively lower mental QOL summary score (Mental component summary: MCS) in SF-36

Exclusion criteria

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 or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims" in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are troubled with pollinosis, house dust allergy, or asthma 7. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the principal investigator

Design outcomes

Primary

Measure	Time frame
SF-36 (Medical Outcomes Study Short-Form 36-Item Health. Survey) *Assess at 0, 6, and 12 weeks after consuming	—

Secondary

Measure	Time frame
OSA sleep inventory MA version *Assess at 0, 6, and 12 weeks after consuming	—

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026