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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000060011 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Orthomedico Inc. | OTHER |
| Indena Japan Co. LTD | UNKNOWN |
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The goal of this clinical trial is to test in Japanese adults who experience concerns regarding urinary frequency. The main question it aims to answer is:
•Does consumption of Cranberry Phospholipids reduce daytime urinary frequency?
Participants will be given the following tasks:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranberry Phospholipids | Active Comparator | Take two tablets (containing 120 mg cranberry phospholipids/tablet) |
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| Placebo | Placebo Comparator | Take two tablets (containing 0 mg cranberry phospholipids/tablet) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranberry Phospholipids | Dietary Supplement | Take two tablets will be taken once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Measured value for the Overactive Bladder Questionnaire (OAB-q) questionnaire item "frequent urination during the daytime hours" after the 8-week intervention | Using OAB-q, we evaluate OAB-specific quality of life (QOL). The questionnaire have 33 items, including 8 items measuring "symptom bother" and 25 items measuring "impact on QOL," with each item rated on a 6-point scale."Impact on QOL" is scored across four domains: "Coping" (8 items), "Concern" (7 items), "Sleep" (5 items), and "Social Interaction" (5 items). Scores are calculated on a scale of 0 to 100, with higher scores indicating a greater degree of difficulty. On the other hand, the "impact on QOL" indicates that the higher the score, the better the QOL. | After the 8-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Individuals whose the response to the OAB-q questionnaire item "frequent urination during the daytime hours" improved by one or more scale points after the 8-week intervention compared to Baseline | Using OAB-q, we evaluate OAB-specific QOL. The questionnaire have 33 items, including 8 items measuring "symptom bother" and 25 items measuring "impact on QOL," with each item rated on a 6-point scale."Impact on QOL" is scored across four domains: "Coping" (8 items), "Concern" (7 items), "Sleep" (5 items), and "Social Interaction" (5 items). Scores are calculated on a scale of 0 to 100, with higher scores indicating a greater degree of difficulty. On the other hand, the "impact on QOL" indicates that the higher the score, the better the QOL. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naoko Suzuki | Contact | +81-3-3818-0610 | group_gakujutsu@orthomedico.jp | |
| Asami Baba, PhD | Contact | +81-3-3818-0610 | asami-baba@orthomedico.jp |
| Name | Affiliation | Role |
|---|---|---|
| Tsuyoshi Takara, MD | Medical Corporation Seishinkai, Takara Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nerima Medical Association Minami-machi Clinic | Recruiting | Nerima-ku | Tokyo | 176-0002 | Japan |
Data sharing will be discussed among the research affiliates after the study is completed.
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| Placebo | Dietary Supplement | Take two tablets will be taken once daily |
|
| Baseline, and after the 8-week intervention |
| The amount of change, and percentage of change from Baseline for the OAB-q questionnaire item "frequent urination during the daytime hours" after the 8-week intervention | Using OAB-q, we evaluate OAB-specific QOL. The questionnaire have 33 items, including 8 items measuring "symptom bother" and 25 items measuring "impact on QOL," with each item rated on a 6-point scale."Impact on QOL" is scored across four domains: "Coping" (8 items), "Concern" (7 items), "Sleep" (5 items), and "Social Interaction" (5 items). Scores are calculated on a scale of 0 to 100, with higher scores indicating a greater degree of difficulty. On the other hand, the "impact on QOL" indicates that the higher the score, the better the QOL. | Baseline, after the 1-week intervention, the 3-week intervention and the 8-week intervention |
| The measured values, amount of changes, and percentage of changes from Baseline for all other questionnaire items of the OAB-q, excluding "frequent urination during the daytime hours," after the 8-week intervention | Using OAB-q, we evaluate OAB-specific QOL. The questionnaire have 33 items, including 8 items measuring "symptom bother" and 25 items measuring "impact on QOL," with each item rated on a 6-point scale."Impact on QOL" is scored across four domains: "Coping" (8 items), "Concern" (7 items), "Sleep" (5 items), and "Social Interaction" (5 items). Scores are calculated on a scale of 0 to 100, with higher scores indicating a greater degree of difficulty. On the other hand, the "impact on QOL" indicates that the higher the score, the better the QOL. | Baseline, after the 1-week intervention, the 3-week intervention and the 8-week intervention |
| The measured values, and amount of changes and percentage of changes from Period 1 for the average frequency of urination during the daytime, during the nighttime, and all day, as measured during Periods 2 to 9 | Participants will maintain a daily diary of their urination frequency during two distinct periods: for 7 days immediately preceding the Baseline, and from the beginning of the intervention until the day before the final examination. | Period 1 (7 days prior to Baseline), Period 2~9 (periods separated by 7 days from the start of intervention) |
| Individuals who experienced adverse events | During the trial period, if a participant exhibits any clinically significant "new manifestation of abnormality" or "aggravation" in his/her physical signs and symptoms, it is considered to be an adverse event. | After the 8-week intervention |
| Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at Baseline | The ratio of cases which had test items stated in urinalysis and peripheral blood examination within their respective standard ranges before intervention but exceeded the ranges after intervention are calculated, intergroup comparison at each time point is performed using tests for comparing proportions. | Baseline, and after the 8-week intervention |
| Body height | Body height is measured using a height meter. | Baseline, and after the 8-week intervention |
| Body weight | Body weight is measured using a body scale. | Baseline, and after the 8-week intervention |
| Blood pressure | Systolic and diastolic blood pressure are measured using a digital wrist-type sphygmomanometer. | Baseline, and after the 8-week intervention |
| Urinalysis | A urine sample (approximately 10 mL) will be collected from each participant, and the samples will be sent to LSI Medience Corporation for analysis. | Baseline, and after the 8-week intervention |
| Peripheral blood examination | A venous blood sample (approximately 10 mL) will be collected from each participant, and the samples will be sent to LSI Medience Corporation for analysis. | Baseline, and after the 8-week intervention |
| Medical Corporation Seishinkai, Takara Clinic | Recruiting | Shinagawa-Ku | Tokyo | 141-0022 | Japan |
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