EUCTR2014-000303-28-DE进行中（未招募）1 期
Multi-center, prospective, controlled, randomized, single-blinded study to evaluate the efficacy of vibrotactile neuro-feedback additionally to intake of Ginkgo biloba special extract EGb 761® for the treament of presby vertigo.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Men and women aged 60 or older
- •2. subjective chronic vertigo for > 3 months
- •3. Dizziness Handicap Inventory (DHI) score > 25
- •4. Geriatrischen Standard Balance Defizit Test determined risk of falling > 40 %
- •5. Written informed consent
- •6. Willingness and ability to participate all stuy specific tasks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. hemorrhagic diatheses, coagulation disorder, Ulcus ventriculi or duodeni
- •2. Diseases affecting resorption
- •3. Severe or acute general diseases within the last 4 weeks
- •4. Acute or chronic otologic, neurologic or psychiatric diseases within the last 12 months except age-related vertigo, i.e. depression, stroke, TIA, Parkinson-disease, Alzheimer-disease, seizure disorders, craniocerebral trauma, brain haemorrhage, Multiple sklerosis, ISSHL, morbus menière, benign positional vertigo
- •5. Severe or instable internal disorders such as
- •a. Malignoma with the exception of carcinoma in situ, adequately treated basal cell carcinoma or curative treated malignom more than 3 years ago
- •b. uncontrolled arterial hypertension
- •c. uncontrolled Diabetes mellitus
- •d. Known cardiac arrhythmia (Lown-classification IVb and V)
- •e. Heart failure NYHA III or IV
- •f. Active bacterial infections
- •g. Severe coronary heart disease (State IV Canadian Cardiovascular Society), instable angina pectoris, heart attack within the last 6 months
- •6. clinically significant changes ECG- or Lab, that need treatment
- •7. Hypersensitivity against one of the ingredients of the study drug
- •8. Substance misuse or addiction current or in medical history
- •9. Participation in other clinical trials within the last 12 weeks
- •10. Concomitant medication out of one of the following substance classes
- •a. anticoagulants (Heparin, Vitamin-K-Antagonist, Dabigatran, Apixaban or Rivaroxaban)
- •b. Antidementics or Nootropics
- •c. benzodiazepines
- •11. Intake of a Ginkgo-biloba products within the last 12 weeks
- •12. Planned surgery or hospitalization during study period
- •13. Other factors that prevent from study participation
- •14. People, who are in institutional care due to official or ancillary order
- •15. People, who depend on sponsor or investigator
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