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临床试验/CTRI/2017/06/008797
CTRI/2017/06/008797已完成2 期

A Randomized, Single blind, Prospective, Multi-center, Phase II, Clinical Study to Evaluate Efficacy and Safety of Three Different Topical Formulations in Subjects Suffering from Headache. - NI

Emami Ltd0 个研究点目标入组 90 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90

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.Diagnosed with Tension Type Headache as per the ICHD II criteria (History of Headache for >= 1 Year, having at least 2 days of headache in a month, and the headache lasts for >= 4 hours if untreated)
  • 2.Subjects using Local application like oil, ointment, balm etc. the treatment of the headache.
  • 3.Subjects not having severe Headache requiring continues medical management
  • 4.Subjects signing written informed consent and ready to comply with the protocol requirement

排除标准

  • 1.Headache due to conditions like migraine, sinusitis, cold, fever or any other underlying disease
  • 2.History of surgery of the Head, Neck, Eyes, Ear, and Nose at least one year prior to recruitment in the study
  • 3.Subjects who use regular analgesics for headache relief
  • 4.Use of any other investigational drug within 1 month prior to randomization
  • 5.Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease
  • 6.Subjects using oral contraceptives
  • 7.Known other active and serious medical or surgical disease
  • 8.Pregnancy & Lactation
  • 9.Known hypersensitivity to compounds similar to the trial drug.

研究者

发起方
Emami Ltd

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