Open labelled Prospective Randomized single Arm clinical trial to Evaluate the efficacy and safety of Migreez Tablet and nasal drop in management of Chronic Migrain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 1.Reduction in migraine pain intensity over 30 days by a validated pain scale
研究概览
简要总结
Migraine is a neurological condition characterized by recurring episodes of moderate to severe headaches, often accompanied by other symptoms like nausea, vomiting, and sensitivity to light (photophobia) or sound (phonophobia). Migraines may be preceded by an aura, which includes visual disturbances or other sensory changes. It is more than just a headache, involving complex interactions in the brain that lead to pain and other symptoms. The Migreez tablets & Nasal drops are Ayurvedic formulations designed to relieve one sided throbbing headache, Nausea & vomiting, Sensitivity to light & sound. This trial aims to document the efficacy and safety of Migreez Tablets & Drops in relieving migraine associated pain & headache, other symptoms like nausea, vomiting and sensitivity to light and sound, in individuals suffering from chronic migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with having with symptoms of Migraine one sided throbbing headache /Nausea & vomiting Sensitivity to light & sound more than 3 months Completed the screening process within 3 days prior to randomization Study participant has understood and signed the informed consent form to participate in the study.
- •Study participant willing to be available for the entire study period and adhere to protocol requirements as evidenced by signing the informed consent document.
排除标准
- •Complicated and special types of gastritis hemorrhage peptic ulcer cholelithiasis cholecystitis, dysplasia of gastric mucosa or pathological diagnosis of suspected malignant change Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, hepatic, immunologic, endocrine, or neurologic systems or psychiatric disease as determined by the investigator(s).
- •Pregnant and lactating women; Had a history of allergy from trial medication; Subject who has been involved with another experimental trial within the past 30 days from the date of recruitment.
- •Subjects using over-the-counter or prescription anti-reflux agents (Allopathic, Herbal, Homeopathic, Ayurveda, Unani, Siddha medicines) within the past 14 days from the date of recruitment.
结局指标
主要结局
1.Reduction in migraine pain intensity over 30 days by a validated pain scale
时间窗: 1 Visit 1 Baseline | 2 Visit 2 Day 15 | 3 Visit 3 Day 30
2.Decrease in the number of migraine episodes per week over 30 days
时间窗: 1 Visit 1 Baseline | 2 Visit 2 Day 15 | 3 Visit 3 Day 30
3.Reduction in the occurrence of nausea, vomiting, photophobia, and phono phobia over 30 days
时间窗: 1 Visit 1 Baseline | 2 Visit 2 Day 15 | 3 Visit 3 Day 30
4.Time to significant relief from acute migraine pain over 30 days
时间窗: 1 Visit 1 Baseline | 2 Visit 2 Day 15 | 3 Visit 3 Day 30
次要结局
- Safety of Migreez Tablet & Drop in chronic migraine patients.(1 Visit 1 Baseline)
研究者
Dr MM Godbole
Yashwant Ayurvedic College