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
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
- 否
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
干预措施: placebo (Drug)
propranolol
干预措施: propranolol (Drug)
Quince's oxymel
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
Mohammad Hashem Hashempur
MD, PhD of Iranian traditional medicine
Shiraz University of Medical Sciences
