A Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Women With Urinary Freque… (NCT07571616) | Clinical Trial Compass
CompletedNot Applicable
A Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Women With Urinary Frequency and Leakage Symptoms
China19 participantsStarted 2024-07-15
Plain-language summary
This was a single-center, open-label, single-arm, exploratory human study evaluating NatureU Pelvic Health Pumpkin Seed in adult women with urinary frequency and urinary leakage symptoms. Twenty-seven participants were recruited, 19 were screened and enrolled, and 19 completed the study and were included in the effectiveness analysis. Participants took the study product for 7 consecutive days, one tablet after lunch and one tablet after dinner, for a total daily intake of two tablets. Outcomes were assessed before product intake and after 7 days of use. The main outcomes included the Women Toileting Behavior Scale (WTBS) and the Incontinence Quality of Life questionnaire (I-QOL). Patient Global Impression of Improvement (PGI-I), waist circumference, fasting blood glucose, blood pressure, and safety observations were also assessed.
Who can participate
Age range35 Years – 55 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
* Adult woman aged 35 to 55 years, inclusive.
* Had urinary frequency and urinary leakage symptoms.
* Body weight at least 50 kg.
* Body mass index between 18.5 and 23.9 kg/m2, inclusive.
* Able to maintain normal healthy routines during the study period.
* Able to abstain from alcohol during the study period.
Exclusion Criteria:
* Pregnant or breastfeeding.
* Recent pregnancy plans.
* Known allergy or hypersensitivity to product ingredients, including pumpkin or soybean.
* History of multiple food allergies.
* Diagnosed diabetes or other metabolic disease.
* Clinically significant abnormalities in blood glucose, blood pressure, physical examination, or vital signs as judged by the investigator.
* Acute or chronic inflammatory disease, including influenza A, within the previous month.
* Participation in any other clinical trial within 1 month before first use of the study product.
* Clinically significant disease within the previous 6 months judged by the investigator to make participation inappropriate.
* Acute illness or concomitant medication use from screening to first use of the study product.
* Surgery within the previous 3 months.
* Blood donation or major blood loss greater than 450 mL within the previous 3 months.
* Difficulty swallowing.
* Gastrointestinal disease history affecting product intake.
* Any disease that increase…
What they're measuring
1
Change From Baseline in Women Toileting Behavior Scale Total Score
Timeframe: Baseline and Day 8 after 7 days of product intake