Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence: A Randomized Double-Blind Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the effectiveness and safety of Chinese herbal medicine in improving urinary incontinence symptoms among older adults. Urinary incontinence is a common condition in aging populations that can significantly impact quality of life, yet existing treatments are often limited by side effects or insufficient efficacy.
The primary research question is whether a standardized Chinese herbal formula can reduce the frequency and severity of urinary incontinence compared to a placebo. We hypothesize that participants receiving the herbal intervention will demonstrate greater improvement in urinary symptoms and quality of life measures than those receiving placebo, without significant adverse effects.
To test this hypothesis, a randomized, double-blind, placebo-controlled clinical trial will be conducted. Eligible older adults will be randomly assigned to receive either the herbal treatment or a matched placebo over a defined study period. Outcomes will include validated measures of urinary incontinence severity, frequency of episodes, and patient-reported quality of life.
Potential benefits of this research include generating high-quality evidence on the effectiveness and safety of Chinese herbal medicine for urinary incontinence, which may inform clinical practice and expand treatment options for older adults. If effective, this intervention could offer a complementary or alternative approach with fewer side effects, contributing to improved symptom management and overall well-being in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experience symptoms of urinary incontinence (including stress, urge, or mixed incontinence) as confirmed by clinical assessment or validated screening tools.
- •Able to understand the study procedures and provide informed consent.
- •Willing and able to comply with study requirements, including attending study visits, and completing questionnaires.
- •Stable general medical condition that, in the opinion of the investigator, does not interfere with participation in the study.
- •Not currently participating in another interventional clinical trial that could affect urinary incontinence outcomes.
排除标准
- •Inability to provide informed consent due to severe cognitive impairment or dementia.
- •Known allergy or hypersensitivity to any component of the Chinese herbal medicine formulation.
- •Presence of severe, unstable, or uncontrolled medical conditions that may pose a safety risk or interfere with participation, as determined by the investigator.
- •Active urinary tract infection at the time of screening (eligible for reconsideration after treatment if appropriate).
- •Current use of treatments for urinary incontinence that cannot be safely maintained at a stable dose throughout the study period.
- •Significant neurological or urological conditions that severely affect bladder function, unless stable and deemed appropriate by the investigator.
- •Participation in another interventional clinical trial that could influence study outcomes or participant safety.
- •Any other condition that, in the opinion of the investigator, would compromise participant safety, study adherence, or data integrity.
研究者
John Yang
Chair, Deparment of Traditional Chinese Medicine
Kwantlen Polytechnic University