Essential Oils for Urinary Symptoms in Multiple Sclerosis Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Oran 1

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Essential Oil Blend (Lavender, Rosemary)

    Other intervention

    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.

  • Neutral Carrier Oil (Apricot Kernel Oil)

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Essential Oil Aromatherapy GroupExperimental treatment 1 intervention
Group B: Placebo Oil GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overactive Bladder Symptom Score (OABSS)

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). \[Time Frame: Baseline and Week 6\]

Time frame
Baseline, and Week 6
2

Qualiveen questionnaire

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). \[Time Frame: Baseline and Week 6\]

Time frame
Baseline and Week 6

Secondary outcomes

Other outcomes

Sponsors and contacts

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