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临床试验/NCT02179775
NCT02179775Unknown不适用

Comparison of Effectiveness of "Sekanjabin e Safarjali" (Quince Oxymel), Propranolol and Placebo in the Prevention of Migraine Attacks in Patients With Simultaneous Upper Gastrointestinal Dysfunction

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
45
试验地点
1
主要终点
Pain Scores as assessed by the Visual Analog Scale

研究概览

简要总结

The purpose of this study is to determine whether Quince Oxymel is effective in the prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.

详细描述

This is a randomized, placebo-controlled, triple blinded clinical study to evaluate the effects of oral use of "Sekanjebin e Safarjali" (Quince Oxymel) in the Prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.45 patients with Migraine headache aged between 15-70, after taking signed informed consent, according to the International headache society criteria for headache [2] are included in this trial. 45 cases with Migraine headache with simultaneous upper gastrointestinal dysfunction will allocate to three arms by using simple randomization. Quince Oxymel, propranolol and placebo will be given as encoded, innominate bottles with the same shape and color. Quince oxymel and placebo will be prescribed as 10 cc, three times a day for 4 weeks. Frequency, duration and intensity of Migraine Attacks at the beginning time and during 4 weeks of trial, will be evaluated, as the primary outcome measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • minimum age of 18 years old
  • giving a written informed consent
  • having at least 2 migraine attacks per month

排除标准

  • patients older than 70 years old
  • patients with Diabetes mellitus
  • patients with chronic obstructive pulmonary disease and asthma
  • pregnancy
  • severe depression
  • patients affected by sexual disorders
  • bradyarrhythmic patients
  • positive history of hypersensitivity reactions to quince, ginger, propranolol or naproxen

研究组 & 干预措施

placebo

Placebo Comparator

干预措施: placebo (Drug)

propranolol

Active Comparator

干预措施: propranolol (Drug)

Quince's oxymel

Active Comparator

干预措施: Quince's oxymel (Drug)

结局指标

主要结局

Pain Scores as assessed by the Visual Analog Scale

时间窗: 4 weeks

frequency of headache attacks

时间窗: 4 weeks

duration of headache attacks

时间窗: 4 weeks

次要结局

  • self-reported improvement of upper gastrointestinal symptoms (by percent)(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Hashem Hashempur

MD, PhD of Iranian traditional medicine

Shiraz University of Medical Sciences

研究点 (1)

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