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Essential Oils for Urinary Symptoms in Multiple Sclerosis Patients (AROMA-MS)

16. mai 2026 oppdatert av: Saida Hanane Zitouni-Nourine, University of Oran 1

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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Algerie
      • Oran, Algerie
        • Zitouni-Nourine Saida Hanane
    • Oran Province
      • Oran, Oran Province, Algerie, 31000
        • Aboubakr abdelmadjid
        • Ta kontakt med:
          • Aboubakr Abdelmadjid, Professor
          • Telefonnummer: (+213) 041 70 50 92
          • E-post: contact@ehuoran.dz

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Essential Oil Aromatherapy Group
Annen: Essential Oil Blend (Lavender, Rosemary)
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.
Placebo komparator: Placebo Oil Group
Annen: Neutral Carrier Oil (Apricot Kernel Oil)
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overactive Bladder Symptom Score (OABSS)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Oran 1

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. desember 2026

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

16. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UO1-HE-SEP-URO-2025-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere