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
調査の概要
状態
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：Zitouni-Nourine Saida Hanane
- 電話番号：+213556623080
- メール：zitouni.saida@univ-oran1.dz
研究場所
-
-
-
Oran、アルジェリア
- Zitouni-Nourine Saida Hanane
-
-
Oran Province
-
Oran、Oran Province、アルジェリア、31000
- Aboubakr abdelmadjid
-
コンタクト：
- Aboubakr Abdelmadjid, Professor
- 電話番号：(+213) 041 70 50 92
- メール：contact@ehuoran.dz
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
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：支持療法
- 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 |
|---|---|
|
実験的：Essential Oil Aromatherapy Group
|
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.
|
|
プラセボコンパレーター：Placebo Oil Group
|
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.
|
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 |
|---|---|---|
|
Overactive Bladder Symptom Score (OABSS)
時間枠：Baseline, and Week 6
|
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
|
|
Qualiveen questionnaire
時間枠：Baseline and Week 6
|
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
|
協力者と研究者
スポンサー
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
- UO1-HE-SEP-URO-2025-001
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?
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。