NCT07599189尚未招募不适用
Efficacy and Safety of Essential Oil Aromatherapy on Neurogenic Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis: A Randomized Single-Blind Placebo-Controlled Clinical Trial.
University of Oran 12 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
The goal of this clinical trial is to learn if essential oil aromatherapy works to improve urinary symptoms in adults with multiple sclerosis. It will also learn about the safety of essential oil use in this population.
The main questions it aims to answer are:
- Does essential oil aromatherapy reduce urinary urgency, frequency, and incontinence episodes in participants with multiple sclerosis?
- What medical problems do participants have when using essential oil aromatherapy?
Researchers will compare essential oil aromatherapy to a placebo (a look-alike neutral oil with no therapeutic properties) to see if essential oil aromatherapy works to improve urinary symptoms in multiple sclerosis patients.
Participants will:
- Use essential oil aromatherapy or a placebo oil every day for 6 weeks
- Complete a urinary symptom scales to record the frequency, urgency, and any leakage episodes each day
- Fill out quality of life questionnaires at the beginning and end of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Multiple Sclerosis (any form)
- •Documented lower urinary tract symptoms defined by an Overactive Bladder Symptom Score (OABSS) ≥ 3 at screening
- •Age between 18 and 65 years
- •Willing and able to provide written informed consent
- •Capable of performing daily topical self-application of the study oil, or having a caregiver available to assist throughout the study period
排除标准
- •Active urinary tract infection confirmed by urine culture at screening
- •Pre-existing urological condition unrelated to Multiple Sclerosis (e.g., bladder cancer, benign prostatic hyperplasia, or interstitial cystitis)
- •Known allergy or hypersensitivity to essential oils, apricot kernel oil, lavender, or rosemary
- •Active skin lesions, wounds, or dermatological conditions on the lower abdomen at the intended site of application
- •Pregnancy, breastfeeding, or planning to become pregnant during the study period
- •Significant cognitive impairment preventing understanding of study procedures or completion of questionnaires
- •Current use of an indwelling urinary catheter or practice of intermittent self-catheterization
研究者
Saida Hanane Zitouni-Nourine
Associate Professor
University of Oran 1
研究点 (2)
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