Comparative Efficacy and Safety of Propranolol Versus Amantadine in Controlling Tremors in Parkinson's Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in tremor severity
研究概览
简要总结
Parkinson's disease is a common brain disorder in older adults that causes tremors (shaking), stiffness, and problems with movement. Among these symptoms, tremors-especially those that occur at rest-can be distressing and interfere with daily life. This study aims to compare two commonly used medications, propranolol and amantadine, to determine which one is more effective and safer in reducing tremors in people with Parkinson's disease.
This clinical trial was conducted with 220 adults aged 50 to 80 years who had a confirmed diagnosis of Parkinson's disease and noticeable resting tremors. Participants were randomly assigned to receive either propranolol or amantadine for 12 weeks, while continuing their usual Parkinson's medications. Tremor severity was measured using a standard scoring tool known as the Unified Parkinson's Disease Rating Scale (UPDRS). Quality of life and side effects were also closely monitored.
The hypothesis is that propranolol would be more effective in reducing tremor severity than amantadine, though it might be associated with more side effects. Both medications were given in tablet form, twice daily, and doses were adjusted based on patient response and tolerance.
At the end of the study, both groups showed improvement, but propranolol was more effective at reducing tremors. However, it caused more side effects such as tiredness and dizziness. Quality of life improved in both groups with no major difference between them. This study may help doctors decide which medication is more suitable for treating tremors in Parkinson's disease, based on the patient's health status and side effect tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •UK Parkinson's Disease Society Brain Bank criteria [7] - Parkinson's Disease.
- •Aged between 50 and 80 years.
- •Significant (resting tremor score, defined as η ≥2 on the UPDRS Part III).
- •At least 4 weeks prior to the study, a stable regimen of PD medication.
排除标准
- •Severe bradycardia, history of asthma, or heart block (used instead of the propranolol group).
- •History of seizures or significant renal impairment (Amantadine group).
- •Cigarette smoking, pregnant or breastfeeding women.
- •Patients with MMSE <
- •Participation in another clinical trial at the same time.
研究组 & 干预措施
Group Propranolol
Received 40 mg of propranolol administered orally twice daily, with dose titration permitted based on clinical response and tolerability, not exceeding 80 mg/day. PD medications remained unchanged during the trial.
干预措施: propranolol (Drug)
Group Amantadine
Received 100 mg of amantadine administered orally twice daily, with dose titration permitted based on clinical response and tolerability, not exceeding 200 mg/day. PD medications remained unchanged during the trial.
干预措施: Amantadine (Drug)
结局指标
主要结局
Change in tremor severity
时间窗: From baseline to 12 weeks after intervention initiation
This measure assessed the severity of resting tremor using Part III (Motor Examination) of the Unified Parkinson's Disease Rating Scale (UPDRS). Each tremor item was scored from 0 to 4, with higher scores reflecting greater severity. The change in tremor scores from baseline to week 12 was used to evaluate and compare the efficacy of propranolol and amantadine in reducing tremor severity among participants with Parkinson's disease.
次要结局
未报告次要终点
研究者
Nabeel Ahmed
Principal Investigator
Multan Medical And Dental College