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临床试验/NCT05897853
NCT05897853已完成不适用

Impact of Vertigoheel® on Patients Suffering From Bilateral Vestibulopathy and Functional Dizziness in a Real-world Setting, Using PRO and QoL - a Non-interventional, Prospective, Mono-center, Observational Study

Ludwig-Maximilians - University of Munich1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Dizziness Handicap Inventory

研究概览

简要总结

In this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product Vertigoheel©. Adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (BVP) or functional dizziness (FD) and assigned to Vertigoheel treatment. Participating patients receive an examination at study start and after 2 months of Vertigoheel treatment. The study focuses on patient reported outcomes assessed by questionnaires.

Vertigo symptoms are assessed by the Dizziness Handicap Inventory questionnaire. Patients' quality of life is assessed by a questionnaire. Body sway is assessed by static posturography. FD patients are additionally tested for depressive and anxiety symptoms by questionnaires. BVP patients are additionally tested for vestibular function by video head impulse test and caloric testing. Adverse events and other observations related to safety (physical examination and vital signs) are evaluated.

Vertigo is a common symptom with significant adverse effects on patients' quality of life. Regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. Vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in Germany as treatment for vertigo of various origins. However, no systematic data are available for Vertigoheel® regarding patient-reported outcomes in BVP and FD as the most accepted endpoint in vertigo studies.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Treatment with Vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study.
  • Bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the Bárány Society
  • Symptoms for > 3 months of moderate to severe intensity according to the dizziness handicap inventory [0 (minimum score) -100 (maximum score)] between 30 to 90 points.
  • ≥18 years of age
  • Legally competent male or female outpatient.
  • Signed informed consent.
  • Not pregnant (as proven by negative pregnancy test in case of woman of childbearing potential before first study drug administration) or breast-feeding.

排除标准

  • Having taken within the last 2 months or currently taking Vertigoheel®.
  • Debilitating acute or chronic illness (i.e. psychiatric illnesses).
  • History of sensitivity to any component of the study drug under observation.
  • Unwilling or unable to comply with all the requirements of the study protocol.
  • Any relationship of dependence with the sponsor or with the investigator.

结局指标

主要结局

Dizziness Handicap Inventory

时间窗: 2 months

Change from baseline in dizziness handicap inventory (DHI) after 2±1 months Vertigoheel® treatment. The DHI, ranging from 0 to 100 with higher scores indicating greater severity, was assessed at two time points: baseline and 2 months.

次要结局

  • Postural Imbalance(2 months)
  • Depressive Symptoms in Functional Dizziness(2 months)
  • Anxiety Symptoms in Functional Dizziness(2 months)
  • Quality of Life (QoL)(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. med. Michael Strupp

Principal Investigator

Ludwig-Maximilians - University of Munich

研究点 (1)

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