CTRI/2017/10/010241已完成4 期
A comparative study of efficacy and safety of sodium valproate versus propranolol in prophylaxis of common migraine headache without aura - a randomized, prospective, parallel, open label study
Dr Vikas Sohanlal Sharma0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with history of migraine without aura for at least 6 months prior to evaluation of study. {As per ICHD definition (2.1.1)}
- •2. Patients experience 2-6 migraine attacks per month, but not more than 15 headache days per month.
- •3. Male or female patients in the age group of 18-60 years (both inclusive).
- •4. Patients willing to sign Informed Consent Form.
排除标准
- •1. Patients have more than 15 headache days per month or less than 2 migraine attacks per month.
- •2. Pregnant women or nursing mothers.
- •3. Women of child-bearing potential & all men not willing to follow a reliable & effective birth control measure during the course of the study & at least 3 months after the last visit.
- •4. Patients have commenced any form of migraine prophylactic therapy within 1 month preceding the trial.
- •5. Patients need antidepressant medicines.
- •6. Patientâ??s headache attacks are associated with or attributable to an identifiable cause, such as: premenstrual period; a disease of eye, ear or nose; a neurological disease or psychosis.
- •7. Patients with known history of bronchial asthma.
- •8. Patients with known history of dyslipidemia.
- •9. Patients with diabetes mellitus, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: beta blocker, calcium channel blockers, antidepressants or antiepileptics.
- •10. Patients with history of overuse or require rescue medication for acute migraine treatment for more than 10 treatment days per month or more than 3 days per week.
- •Rescue mediaction: Erogts or triptans, antiemetics, NSAIDS & non opiate analgesics, opiate analgesics, barbiturate hypnotics, corticosteroids, local anesthetics, botulinum toxin or anti-migraine herbal preparations.
- •11. History of acute myocardial infarction or stroke in 6 months preceding the signing of Informed Consent Form.
- •12. History of alcohol or drug dependence.
- •13. Unlikely to maintain a headache diary, comply with the medication or be regular in follow-up visits.
- •14. Any serious disease that would interfere with the compliance to the study protocol.
- •15. These criterias are based on past medical history.
- •Development of exclusion criteria after patient has been randomized will not automatically warrant discontinuing subject from the study.
研究者
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