Essential Oils for Urinary Symptoms in Multiple Sclerosis Patients (AROMA-MS)
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.
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
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Zitouni-Nourine Saida Hanane
- 电话号码：+213556623080
- 邮箱：zitouni.saida@univ-oran1.dz
学习地点
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Oran、阿尔及利亚
- Zitouni-Nourine Saida Hanane
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Oran Province
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Oran、Oran Province、阿尔及利亚、31000
- Aboubakr abdelmadjid
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接触：
- Aboubakr Abdelmadjid, Professor
- 电话号码：(+213) 041 70 50 92
- 邮箱：contact@ehuoran.dz
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Essential Oil Aromatherapy Group
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This intervention consists of a standardized topical blend of Lavender (Lavandula angustifolia) at 3% and Rosemary (Rosmarinus officinalis) at 2%, diluted in apricot kernel oil as a carrier.
The blend was formulated to target neurogenic lower urinary tract symptoms in patients with multiple sclerosis, based on the antispasmodic properties of Lavender and the neuromodulatory and anti-inflammatory properties of Rosemary.
The essential oils used are batch-controlled for chemical purity and concentration.
The blend is applied topically via gentle circular massage on the lower abdomen, for a total duration of 6 consecutive weeks.
This specific combination, route of administration, and target population distinguish this intervention from other aromatherapy studies that have used single oils, inhalation methods, or non-neurological populations.
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安慰剂比较：Placebo Oil Group
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This intervention consists of pure Apricot Kernel oil, used as an inert placebo comparator.
The placebo oil contains no active essential oils or therapeutic compounds.
It is identical to the experimental intervention in terms of appearance, color, viscosity, volume, packaging, and method of application, ensuring effective masking of participants and outcome assessors.
The placebo oil is applied topically via gentle circular massage on the lower abdomen, for a total duration of 6 consecutive weeks, mirroring exactly the administration protocol of the experimental arm.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Overactive Bladder Symptom Score (OABSS)
大体时间：Baseline, and Week 6
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Overactive Bladder Symptom Score (OABSS) (Overactive Bladder Symptom Score) Scale range: minimum 0 - maximum 15. Higher scores indicate a worse outcome (greater severity of overactive bladder symptoms). [Time Frame: Baseline and Week 6] |
Baseline, and Week 6
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Qualiveen questionnaire
大体时间：Baseline and Week 6
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Qualiveen - Urinary Disorder-Specific Quality of Life Questionnaire (Qualiveen, Domain 1: "Bother with Limitations") Scale range: minimum 0 - maximum 4 per item (9 items, total domain score = sum of items ÷ 9). Higher scores indicate a worse outcome (greater bother related to urinary problems). [Time Frame: Baseline and Week 6] |
Baseline and Week 6
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- UO1-HE-SEP-URO-2025-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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