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临床试验/CTRI/2010/091/000539
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

发起方
Dr. Y K Gupta

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