Randomized controlled clinical trial to evaluate prophylactic properties of Ayurvedic Treatment Protocol in refractory and chronic migraine patients.

Ipca Laboratories Limited1 个研究点分布在 1 个国家目标入组 154 人开始时间: 2012年5月29日最近更新: 2019年3月5日

试验速览

阶段: 3 期
状态: 已完成
发起方: Ipca Laboratories Limited
入组人数: 154
试验地点: 1
主要终点: Mean change in number of headache days

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a Randomized controlled trial to assess theefficacy of Ayurvedic treatment in migraine patients. It is being conducted inAll India Institute of Medical Sciences. The primary objective of this study isto assess the efficacy of Ayurvedic treatment to bring long term remissionamongst migaraine patients.The secondary objective of the study is to assessthe efficacy in reducing the intensity and frequency of pain and associatedsymptoms on migraine patients by using modern scientific parameters (VAS &MIDAS)

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Male or Female patients age 18-65 years.

排除标准

•Patients having migraine with aura, sinusitis induced headache, patients with refractory headache, post traumatic headache, medication over use headache, intracranial hypertension/hypotension and neuralgias and patient with pseudo refractory migraines.

结局指标

主要结局

Mean change in number of headache days

时间窗: The Aurvedic treatment protocol will be given for 120 days and the patients will be then followed up every month for the next 360 days.

次要结局

To assess the efficacy in reducing the intensity and frequency of pain and associated symptoms on migraine patients by using modern scientific parameters (VAS & MIDAS)(7 visits to complete 1 year)

研究者

发起方

Ipca Laboratories Limited

申办方类型

Pharmaceutical industry-Indian

研究点 (1)

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