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 range
35 Years – 55 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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