Comparative Study of Nutraceuticals vs. Conventional Prophylactic Therapy in the Management of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- migraine intensity using The visual analog scale (VAS score)
研究概览
简要总结
Migraine is a common disabling neurological condition that significantly affects quality of life. While traditional prophylactic treatments (e.g., beta-blockers, antiepileptics) are effective, they may be associated with side effects leading to poor adherence. Recent evidence suggests that nutraceuticals like magnesium, riboflavin, and coenzyme Q10 may provide a safer alternative. This study aims to compare the efficacy and tolerability of these two approaches.
详细描述
Primary Objective:
- To compare the reduction in the frequency of migraine attacks between patients receiving conventional prophylactic therapy and those receiving a nutraceutical combination.
Secondary Objectives:
- To evaluate changes in migraine intensity (VAS score), duration, and MIDAS score.
- To assess the side effect profile and patient satisfaction with both interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years
- •- Diagnosed with episodic migraine (ICHD-3 criteria)
- •- ≥4 migraine attacks/month for the past 3 months
- •- Willing to provide informed consent
排除标准
- •• - Chronic migraine (>15 headache days/month)
- •- Use of other prophylactic treatments in past month
- •- History of secondary headaches
- •- Pregnancy or breastfeeding
- •- Significant renal, hepatic, or cardiac disease
研究组 & 干预措施
Group 1
Conventional Therapy
干预措施: Propranolol 80 mg (Drug)
Group 2
Nutraceutical Therapy
干预措施: Magnesium 400Mg (Drug)
结局指标
主要结局
migraine intensity using The visual analog scale (VAS score)
时间窗: 3 months
To evaluate changes in migraine intensity using the visual analog scale (VAS score) in both groups which is one of the pain rating scales. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.
migraine duration
时间窗: 3 months
To evaluate changes in migraine duration in both groups. The shorter the migraine attack, the better.
MIDAS score (Migraine Disability Assessment) Score
时间窗: 3 months
To evaluate changes in MIDAS score (Migraine Disability Assessment) in both groups. Which is a validated, 5-item questionnaire designed to quantify the severity of headache-related disability over the past three months by assessing missed days and reduced productivity in work/school, household chores, and social/family activities. The total score, which can range from 0 to 270, indicates the overall impact of migraines on daily functioning, with higher scores signifying greater disability. MIDAS score. Disability. MIDAS grade ; 0-5. Little or no disability. I ; 6-10. Mild disability. II ; 11-20. Moderate disability.
次要结局
- changes in the frequency of migraine attacks(3 months)
- side effect profile(3 months)
- patient satisfaction(3 months)
研究者
Marwa Ahmed Kamal Tolba
Associate professor clinical pharmacy department -faculty of pharmacy- fayoum university
Fayoum University