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Набор скоро начнётся NCT07599189

Essential Oils for Urinary Symptoms in Multiple Sclerosis Patients

Без фазы С лечением Multiple Sclerosis (MS) Neurogenic Bladder Disorder Urinary Incontinence (UI) Urinary Urgency

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Essential Oil Blend (Lavender, Rosemary), Neutral Carrier Oil (Apricot Kernel Oil).
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis (MS), Neurogenic Bladder Disorder, Urinary Incontinence (UI), Urinary Urgency. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Algeria
Следующий шаг
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Официальное название

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.

Обзор

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

Вмешательства

  • Другое 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 concentr
  • Другое 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 week

Первичные конечные точки

  • Overactive Bladder Symptom Score (OABSS) [Срок оценки: Baseline, and Week 6]
  • Qualiveen questionnaire [Срок оценки: Baseline and Week 6]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Algeria · 2 центра
  • Aboubakr abdelmadjid — Oran
  • Zitouni-Nourine Saida Hanane — Oran

Идентификаторы

NCT: NCT07599189 · UO1-HE-SEP-URO-2025-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗