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COMPLETED
NCT07571616
NA

A Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Women With Urinary Frequency and Leakage Symptoms

Sponsor: OmniSolutions Laboratory Holdings Limited

View on ClinicalTrials.gov

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.

Official title: A Single-Center, Open-Label, Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Adult Women With Urinary Frequency and Urinary Leakage Symptoms

Key Details

Gender

FEMALE

Age Range

35 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

19

Start Date

2024-07-15

Completion Date

2024-07-22

Last Updated

2026-05-07

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

NatureU Pelvic Health Pumpkin Seed

NatureU Pelvic Health Pumpkin Seed is an oral functional food product containing pumpkin seed extract, soybean extract, vitamin D3, sorbitol, maltodextrin, microcrystalline cellulose, and magnesium stearate. Participants took one tablet after lunch and one tablet after dinner each day for 7 consecutive days.

Locations (1)

Dao County People's Hospital

Yongzhou, Hunan, China