Evaluation of Efficacy and Safety of Menthoplus Balm in Subjects Suffering from Tension Type Headache
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Percentage of subjects with total or meaningful headache relief
研究概览
简要总结
It is a clinical study to evaluate efficacy and safety of the Menthoplus Balm in Subjects Suffering from Tension Type Headache. The study will be carried out at 1-2 center in India. Subjects will be asked to use Menthoplus balm as and when headache occurs for 15 days. The primary objectives of the study will be to assess percentage of subjects with total or meaningful headache relief and change in pain (Headache) intensity. Secondary objectives of the study will be to assess pain free period after 1 hour and 2 hours, use of rescue medications, onset and duration of action as pain (headache) reliever of Menthoplus Balm, satisfaction of the quality of sleep, quality of pain relief (ability to get back to normal) action of Menthoplus balm, global assessment of overall change as assessed by physician and subjects, global assessment of tolerability of study product and adverse events including vitals on baseline Visit, visit 1 (Day 7), Visit 2 (Day 15)
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed to have Tension Type Headache as per the ICHD II criteria.
- •Headache without any serious medical or surgical condition requiring the continuous use of NSAIDs for pain relief.
- •Willing to comply with all requirements of the study.
排除标准
- •Headache due to conditions like migraine, sinusitis, headache, fever or any other underlying disease
- •History of surgery of the Head, Neck, Eyes, Ear, and Nose at least one year prior to recruitment in the study
- •Subjects who use regular analgesics for headache relief
- •Use of any other investigational drug within 1 month prior to randomization
- •Any medical conditions which may interfere with efficacy and or safety of the treatment with the investigational product
- •Known other active and serious medical or surgical disease
- •Pregnancy and Lactation
- •Known hypersensitivity to any ingredients of the trial drug.
- •Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the study.
结局指标
主要结局
1. Percentage of subjects with total or meaningful headache relief
时间窗: Baseline Visit, visit 1 (Day 7), Visit 2 (Day 15)
2. Change in pain (Headache) intensity
时间窗: Baseline Visit, visit 1 (Day 7), Visit 2 (Day 15)
次要结局
- 1. Pain free period after 1 hour and 2 hours(2. Use of rescue medications)
研究者
Dr Priyanka Patil
Shree Sai Clinic