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
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