DRKS00007633已完成4 期
Multicenter, prospective, controlled randomized, single-blind study to evaluate the efficacy of vibrotactile neuro-feedback in addition to Ginkgo biloba special extract EGb 761® for the treatment of presbyvertigo
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 one（—）
- 性别
- All
入选标准
- •1. Subjective chronic vertigo for > 3 months
- •2. Dizziness Handicap Inventory (DHI) score > 25
- •3. geriatric standard balance deficit test determined risk of falling > 40%
- •4. Written informed consent
- •5. Willingness and ability to participate in all study specific tasks
排除标准
- •1. Hemorrhagic diatheses, coagulation disorder, ulcus ventriculi or duodeni
- •2. Conditions which may impair resorption
- •3. Severe or acute general disorder within the last 4 weeks
- •4. Acute or chronic otologic, neurologic or psychiatric disease during the last 12 months except presbyvertigo such as depression, stroke, TIA, Parkinson’s disease, Alzheimer’s disease, seizures, traumatic brain injury, cerebral hemorrhage, multiple sclerosis, sudden idiopathic hearing loss, Menière’s disease, benign positional vertigo
- •5. Severe or unstable medical disorders such as
- •a. Malignoma with exception 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 classes IVb and V)
- •e. Heart failure NYHA III or IV
- •f. Active bacterial infection
- •g. Severe coronary heart disease (State IV Canadian Cardiovascular Society), instable angina pectoris, heart attack within the last 6 months
- •6. Presence of clinically significant ECG or laboratory abnormalities
- •7. Hypersensitivity to one of the ingredients of the study drug
- •8. Current substance abuse or addiction or history thereof
- •9. Participation in another clinical trial during the past 12 weeks
- •10. Concomitant medication out of one of the following substant classes
- •a. anticoagulants (heparin, vitamine-K-antagonists, dabigatran, apixaban or rivaroxaban)
- •b. Anti-dementia drugs or nootropics
- •c. Benzodiazepines
- •11. Intake of any Ginkgo biloba preparation within the last 12 weeks
- •12. Planned surgery or hospital stay during study
- •13. Other factors which call into question the study participation (e.g. lack of understanding of nature and scope of the study, insufficient knowledge of German language)
- •14 people who are located in an institution on judicial or administrative order
- •15. Persons who are dependent from the sponsor or investigator
研究者
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