ACTRN12624000037505招募中2 期
A Phase IIb Double-Blind Randomised Placebo-Controlled Trial assessing the efficacy of a Chinese Medicine formulation for Dizziness and Vertigo
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Have a diagnosed dizziness/vertigo condition for greater or equal to 3 months (e.g. Meniere’s disease)
- •Experiences dizziness/vertigo symptoms greater or equal to once per month
排除标准
- •Medical history
- •-Current, clinically significant acute disease
- •-Indicators of an unmanaged and clinically significant chronic disease (as per participant self-reporting and investigator review)
- •-History of a physical head injury that has current, clinically significant sequela
- •-History of a CVA (stroke) or TIA (mini-stroke) or brain injury that has been diagnosed as the cause of the dizziness/vertigo symptoms
- •-A diagnosis of diabetes, pre-diabetes or insulin resistance
- •-Diagnosed bleeding disorder
- •-Clinically significant history of epistaxis (nose bleeds) that requires medical intervention to achieve haemostasis
- •-Recent (in the last 3 months) surgery on the eyes, brain or spinal cord
- •-Planned surgery during the 12 weeks of the trial
- •-Current stomach ulcer(s) or symptoms of stomach ulcers (e.g. gastritis) or currently taking medication (regular or PRN) to treat/prevent a stomach ulcer
- •-Any clinical indicators of current, clinically significant dehydration (e.g. oliguria, chronic thirst)
- •-Unstable or newly diagnosed (in last 3 months) cardiac condition
- •-Any current condition characterised by severe diarrhoea, severe constipation, excessive sweating or dry cough
- •-Any condition where the maintenance of fluid balance is important (e.g. may include certain cardiac or kidney conditions. Such conditions may be indicated by the use of potassium or other electrolytes supplements)
- •-Known history of hypotension (less than 90 systolic or greater than 60 diastolic) or uncontrolled hypertension (as per participant self-reporting)
- •Mental health and related conditions
- •-Diagnosed, severe mental illness (e.g. by a psychiatrist)
- •-Severe cognitive impairment e.g. dementia
- •-Current or recent (in last 28 days) alcoholism (>14 standard drinks per week) or current or recent (in last 28 days) recreational drug use
- •Medications
- •-Current or foreseeable use of nasal sprays during the trial
- •-Current use of diabetic medication
- •-Current use of prescription diuretics (supplements with diuretic action are permissible)
- •-Current use of any prescription anti-coagulant or anti-platelet medicine including regular aspirin (PRN use of aspirin is permissible)
- •-Current use (regular or PRN) of pentobarbital
- •-Current use (regular or PRN) of any benzodiazepine medication
- •-Concurrent use of any supplement/medication containing any of the ingredients in the IMP
- •-Those who are pregnant or breast-feeding
- •-Unwilling to use contraception throughout the trial
- •-Concurrent use of any supplement/medication with a known interaction with any IMP ingredient
- •-Known allergy or intolerance to any of the ingredients in the IMP
- •Pathology abnormalities
- •- Screening pathology testing indicative of clinically significant potassium or sodium below the LLN
- •-Screening pathology testing indicative of clinically significant abnormal fasted glucose and/or HbA1c
- •-Screening pathology testing indicative of clinically significant anaemia (e.g. Red blood count, haematocrit or haemoglobin significantly below the LLN) or thrombocytopenia (platelets significantly below LLN)
- •-Screening pathology indicative of clinically significant abnormal clotting (e.g. prothrombin time (PT) significantly outside normal limits)
- •-Screening pathology testing of 25-hydroxy-vitamin D less than or equal to 30 nmol/L
研究者
相似试验
已完成
2 期
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosisiver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic SteatohepatitisJPRN-jRCT2080223975Bristol-Myers Squibb K.K.160
已完成
不适用
A Phase II Randomised Double-Blind, placebo-controlled clinical trial evaluating the efficacy of Happy Hormones in menopausal women.MenopauseACTRN12621000499886Southern Cross University131
尚未招募
2 期
A Clinical Trial to see if a herbal medicine, Urox can prevent the recurrence of a urinary tract infections (UTIs) and cystitis.Recurrent Urinary tract infectionsRecurrent CystitisRenal and Urogenital - Other renal and urogenital disordersInfection - Studies of infection and infectious agentsACTRN12623000861651Southern Cross University202
招募中
1 期
A Phase 2b Study of MK-6024 in Adults with Precirrhotic Nonalcoholic Steatohepatitison-alcoholic steatohepatitisMedDRA version: 22.0Level: PTClassification code: 10053219Term: Non-alcoholic steatohepatitis Class: 100000004871CTIS2022-502647-35-00Merck Sharp & Dohme LLC316
进行中（未招募）
1 期
A Phase II Randomised, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Mexiletine in Patients with Non-Dystrophic Myotonia. - Mexiletine in Non-Dystrophic MyotoniaEUCTR2009-011184-36-GBniversity College London-Joint UCLH/UCL Biomedical (R&D) Unit60