Development of a Unani treatment protocol comprising oral medication Itrifal Mushil and regimental procedures Natul Irrigation and Dalk Massage by Roghan Banafsha in Shaqiqa Migraine without aura NUMC A 2: An open label, single-arm clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Headache frequency and intensity
研究概览
简要总结
This is an open label clinical trail, which will be carried out on 78 patients of migraine without aura. A combination of Unani regimens including Natul (Irrigation) therapy with herbal decoction will be given for 14 days and massage with Roghan Banafsha and Itrifal Mushil by oral route will be given for 28 days to explore the efficacy and safety of Unani regimens in patients of migraine of without aura. The clinical follow-up will be carried out at 0, 7th, 14th and 28th day. The laboratory investigations such as Hb, TLC, DLC, ESR, routine urine examination, LFT and KFT will be done at 0, 7th day and 28th day. Random blood sugar level will be checked at base line. The efficacy of the Unani regimens in patients of migraine without aura will be assessed based on clinical outcomes. The safety of the Unani regimens will be assessed based on clinical and laboratory findings.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •At least five attacks fulfil criteria B–D.
- •Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated).
- •Headache has at least two of the following four characteristics:
- •Unilateral location
- •Pulsating quality
- •Moderate or severe pain intensity
- •Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs).
- •During headache at least one of the following:
- •Nausea and/or vomiting.
- •Photophobia and/ or phonophobia.
- •Not better accounted for by another ICHD3 diagnosis.
排除标准
- •Marked depression, anxiety, psychosis, and epilepsy.
- •Mild cases of migraine
- •Pregnancy and lactation.
- •Major medical illness under treatment.
- •Patients with diseases requiring long term treatment.
- •Use of any other alternative medication during the study period.
- •History of alcohol and drug abuse.
- •Diabetes mellitus since the test drug, i.e., ItrÄ«fal Mushil, contains sugar.
结局指标
主要结局
Headache frequency and intensity
时间窗: 0, 7, 14, 28 Day
次要结局
- Migraine Disability Assessment Score (MIDAS)(0, 7, 14, 28 Day)
研究者
Dr. Athar Parvez Ansari
Regional Research Institute of Unani Medicine, Chennai , CCRUM, Ministry of Ayush, Govt. of India