- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07599189
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zitouni-Nourine Saida Hanane
- Phone Number: +213556623080
- Email: zitouni.saida@univ-oran1.dz
Study Locations
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Oran, Algeria
- Zitouni-Nourine Saida Hanane
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Oran Province
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Oran, Oran Province, Algeria, 31000
- Aboubakr abdelmadjid
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Contact:
- Aboubakr Abdelmadjid, Professor
- Phone Number: (+213) 041 70 50 92
- Email: contact@ehuoran.dz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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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Placebo Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overactive Bladder Symptom Score (OABSS)
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Nervous System Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Autoimmune Diseases
- Immune System Diseases
- Urination Disorders
- Urological Manifestations
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Multiple Sclerosis
- Lower Urinary Tract Symptoms
- Urinary Bladder, Neurogenic
Other Study ID Numbers
- UO1-HE-SEP-URO-2025-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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