Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis: A Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Frequency of headache per month
研究概览
简要总结
The goal of this clinical trial is to compare efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. The main question it aims to answer is:
• Does pizotifen more effective than the combination of amitriptyline-propranolol in migraine prophylaxis?
Participants will be asked to :
- Maintain the provided headache diary accordingly
- Take supplied drugs as described during clinical visits
- Contact principle investigator if there is any issues regarding drug use and/or their adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria.
- •Age at entry: 18 to 50 years (to minimize the risks related to adverse effects of study drugs such as drowsiness, weight gain, A-V conduction block, postural hypotension)
- •Patients not on any prophylactic medications.
- •Patients willing to take part in the study.
- •Patients being able to fill a headache diary successfully & reliably.
排除标准
- •Age <18 years or >50 years
- •Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
- •Patients on prophylactic medication.
- •Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy & breastfeeding etc.
- •Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
研究组 & 干预措施
Amitriptyline-Propranolol
Combination of amitriptyline and propranolol.
Initial 2 weeks:
Amitriptyline 10 mg at bedtime Propranolol 20mg twice daily
Next 2 weeks:
Amitriptyline 25 mg at bedtime Propranolol 20mg three times daily
Next 8 weeks:
Amitriptyline 25 mg at bedtime Propranolol 40mg twice daily
干预措施: Amitriptyline-propranolol (Drug)
Pizotifen
Pizotifen
Initial 2 weeks:
Pizotifen 0.5 mg at bedtime
Next 2 weeks:
Pizotifen 1 mg at bedtime
Next 8 weeks:
Pizotifen 1.5 mg at bedtime
干预措施: Pizotifen (Drug)
结局指标
主要结局
Frequency of headache per month
时间窗: 12 weeks
Comparison of reduction of frequency of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups
Duration of headache per month
时间窗: 12 weeks
Comparison of reduction of total duration of headache attack in immediate last month with initial baseline one month without any medication. These values will be compared between two study groups
Severity of headache
时间窗: 12 weeks
Comparison of reduction of severity of headache attack in immediate last month with initial baseline one month without any medication using visual analogue scale. The visual analogue scale is numbered from 0 to 10. 0 stands for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-9 for severe pain and 10 for very severe unbearable pain. These values will be compared between two study groups
次要结局
- Adverse effects of drugs(12 weeks)
研究者
Khandakar Rashed Ahmed
Principal Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh