Comparative Evaluation of Efficacy and Safety of Oral Propranolol Vs Oral Metoprolol for Prophylaxis in Patients of Migraine in a Tertiary Care Hospital: A Prospective Randomized Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the efficacy of Propranolol versus Metoprolol as Prophylactic Agent in Migraine using The Migraine Disability Assessment Test and Headache Impact Test 6
研究概览
简要总结
The study is a prospective randomized double blind study on the patients of Migraine. The Study will be conducted on 80 patients being divided amongst 2 groups of 40 each in the Department of Neurology and the Department of Pharmacology in the J. A. Group of Hospitals Gwalior, Madhya Pradesh and G. R . Medical College, Gwalior, Madhya Pradesh, India. The groups will be allocated on the basis of numbered chits being chosen by the patients themselves.
The study involves a duration of 12 months and will be focusing on the parameters of Efficacy and Safety.
The patients will be guided and asked to give proper written consent before getting enrolled for the study.
The test drugs under evaluation will be Tablet Propranolol 40 mg once a day after breakfast in one group which will be compared with Tablet Metoprolol 50 mg once a day after breakfast being given for a period of 3 months respectively. The various parameters under consideration will be taken care with regular follow-ups at 4, 8 and 12 weeks respectively. Any ADRs will be reported to the concerned authorities. The expected ADRs will be managed as per the normal treatment policies against the ADRs.
The endpoints of the study will be evaluated after every patient completes their entire study duration and will include the use of standardized scales namely , MIDAS scale, HIT 6 score and for classification of the migraine using ICHD 3 criteria.
The financial burden of the study will be undertaken by the principle investigator.
The blinding of the study will be done by an anonymous expert who is not part of the study and will be revealed at the end of the study.
The study has been approved by the institutional ethics committee of the institution and proper safety protocols will be followed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient will be taken as per International Headache Society Criteria for Migraine with Aura.
- •Patient will be taken as per International Headache Society Criteria for Migraine without Aura.
- •Patients who will be willing to take part in the study with signed and written informed consent.
- •Patients aged between 18-65 years.
- •Patients could be of both male and female.
排除标准
- •Pregnant , breast feeding, child bearing age using contraception.
- •Patients having asthma, bradycardia and COPD.
- •History of Bronchospasm.
- •Patients having Coronary Artery Diseases .
- •Patients less than 18years & more than 65years.
- •Patient whose primary headaches were other than migraine headaches e.g. With a clinical history of stroke or Transient Ischemic Attack.
结局指标
主要结局
To compare the efficacy of Propranolol versus Metoprolol as Prophylactic Agent in Migraine using The Migraine Disability Assessment Test and Headache Impact Test 6
时间窗: Baseline 4 weeks 8 weeks and 12 weeks
次要结局
- To compare the Adverse drug reactions between Propranolol versus Metoprolol which will be used as prophylactic agent in Migraine by maintaining Headache Diary(Baseline 4 weeks 8 weeks & 12 weeks)
研究者
Dr Ramizahmad Maiyuddinbhai Mansuri
Gajra Raja Medical College