Efficacy of Inkibab and Saut of Roghan-i-Pista in Shaqiqa (Migraine) A Randomized placebo controlled, Assessor Blinded clinical trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- •Pain intensity –Migraine Disability Assessment (MIDAS)
研究概览
简要总结
Purpose: Efficacy of Inkibāb and Sa‘ūṭ of Roghan-i-Pista in Shaqīqa (Migraine)
Design :ARandomized Placebo-Controlled Assessor blinded Clinical Trail
Intervention:
Test group: will receive Inkibāb (steam inhalation) followed by Sa‘ūṭ (nasal instillation) of Roghan-i-Pista (pistachio oil).
Control group: will receive only nasal instillation
Outcome Measures:
Primary Outcome:
Pain intensity –Migraine Disability Assessment (MIDAS)
Headache frequency and duration from the headache diary
Secondary Outcome:
Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient Diagnosed cases of Migraine (as per the International Classification of Headache Disorders (ICHD-3) 2.Patient having Pain intensity on the VAS scale between 3-7 3.Patients between the age of 18–50 years 4.Patients of any gender 5.Patients who will give consent and can do follow-up.
排除标准
- •1.Patient use of any migraine prophylactic agents (b-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents, cycle-modulating hormonal drugs, or vessel dilatation agents) within 1 month prior to screen 2.Patient having history or evidence of psychiatric disorder patients 3.Pregnant and lactating women.
结局指标
主要结局
•Pain intensity –Migraine Disability Assessment (MIDAS)
时间窗: Base Line,15th,30th,45th,60th
•Headache frequency and duration from the headache diary
时间窗: Base Line,15th,30th,45th,60th
次要结局
- •Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)22(Base Line,15th,30th,45th,60th)
研究者
Nawaz Ahmed Y
National Institute Of Unani Medicine, Bangalore