Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence
Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence: A Randomized Double-Blind Placebo-Controlled Clinical Trial
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:John Yang, Dr.
- 電話番号:604-599-2286
- メール:john.yang@kpu.ca
研究場所
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British Columbia
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Richmond、British Columbia、カナダ、V6X 3X7
- Student Traditional Chinese Medicine Clinic
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター:対照群
プラセボ
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プラセボ対照
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実験的:Chinese Herbal Intervention
Standardized Chinese herbal medicine
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Chinese Herbal Medicine (CHM) supplement
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
時間枠:From enrollment to approximately week 4.
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Primary outcomes will focus on the frequency and severity of urinary incontinence episodes, measured using validated questionnaires.
Min = 0 and Max = 6, with higher scores indicating more frequent/severe urinary incontinence.
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From enrollment to approximately week 4.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Urinary Incontinence Quality of Life Questionnaire (I-QOL)
時間枠:From enrollment to approximately Week 4.
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Secondary outcomes include quality of life, symptom distress, and any adverse events.
A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores).
The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100.
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From enrollment to approximately Week 4.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- KPU REB # 2022-22
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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