CTRI/2010/091/000539已完成3 期
Randomized, double-blind, placebo-controlled study to compare the efficacy of riboflavin versus propranolol in prophylaxis of migraineAcronym: RiMiPro
Dr. Y K Gupta0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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.Patient of either sex between age group18-65 years who have not received any drug for migraine prophylaxis before.
- •2.Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study.
- •3.More than four migraine episodes per month but no greater than 15 headache days (migraine and non-migraine) in one month during the baseline phase. There should be a gap of at least 48 hours between two episodes. Frequency of non-migraine headaches should be no more than 6 episodes per month.
- •4.No significant abnormalities on clinical examination at baseline.
- •5.Female patients must be either postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception during the complete study period.
- •6.Willing to provide informed consent.
- •7.Patients able to maintain a headache diary.
排除标准
- •1.Patients with headaches other than migraine who cannot differentiate migraine from other headaches.
- •2.Onset of migraine after age of 50 years
- •3.Patients who have taken antipsychotics or antidepressants during the previous 3 months.
- •4.Patients who abuse alcohol or other drugs.
- •5.Patients who use drugs excessively for headache (more than 10 days per month).
- •6.Pregnant or lactating women
- •7.Patients with heart or kidney diseases, asthma or diabetes or otherwise unhealthy.
研究者
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