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The verification study for QOL improvement effects on urination: a randomized double-blind, parallel-group, placebo-controlled study

The verification study for QOL improvement effects on urination: a randomized double-blind, parallel-group, placebo-controlled study - The verification study for QOL improvement effects for urination

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023486
Enrollment
45
Registered
2016-08-04
Start date
2016-08-04
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 adults

Interventions

Duration: 8 weeks Test material: Seaberry extract-P (high-dose: 400 mg) Dose: Take one capsule, twice a day Administration: Take one capsule after breakfast and after dinner Duration: 8 weeks Te

Sponsors

ORTHOMEDICO, Inc.
Lead Sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adults of 40 years old and over 2. The frequency of urination is eight and more per day

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history 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. Currently taking medicines and/or herbal medicines 4. Those who are taking Food for Specified Health Uses , Food with Function Claims a daily basis 5. Allergic to medicines or foods related to the test food of this trial 6. Pregnant, lactating, or planning to get pregnant during the trial period 7. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 8. Judged unsuitable for participating in this trial by physician

Design outcomes

Primary

MeasureTime frame
King's Health Questionnaire *1 Answer the questionnaire at 0 week and at 4 and 8 weeks after the ingestion

Secondary

MeasureTime frame
Overactive Bladder Symptom Score (OABSS) *1 Perform OABSS at 0 week and at 4 and 8 weeks after the ingestion

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