An open clinical trial to evaluate the therapeutic efficacy of Siddha herbal formulation “Athimathura choornam†in the treatment of Oruthalai avartham( migraine )
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The outcome is mainly assessed by clinical symptom, scoring HIT- Headache Impact Test questionnaire.
研究概览
简要总结
It is sigle arm AN OPEN CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC EFFICACY OF SIDDHA HERBAL FORMULATION “ATHIMATHURA CHOORNAM†IN THE TREATMENT OF ORUTHALAI AVARTHAM( MIGRAINE ). In this trail 40 migraine patients will be recruited and the trail drug will be administered 2 gram twice a day along with water for a period of 30 days.During the trail period all the study related data will be recorded and documented in a separate trail master file for each patients.During the study period if any adverse effect will be noticed and referred to pharmacovigilance dept in NIS aand further management will also be given in NIS OPDIPD. the entire trail will be monitored by research monitoring committee of NIS. During this trail all the safety and efficacy parameters will be recorded in the CRF. After completion of the trail all the study related data will be analysed statistically. The outcome of this trail will be published in Indian journal of Medical Research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with complaints of Headache more than 6 months duration (untreated or unsuccessfully treated) 2.Nature of headache-Unilateral and Pulsating quality Moderate or severe pain intensity 3.Aggravation by or causing avoidance of routine physical activity 4.Headache associated with Nausea and/or vomiting Photophobia or Phonophobia.
排除标准
- •1.Pregnant and Lactating women 2.Patient with anti-psychiatric treatment 3.Chronic Alcoholic patients 4.Hypertension, 5.Diabetes mellitus 6.Any systemic disease 7.Past history of head injury 8.History of Sinusitis 9.History of any space occupying lesion in brain.
结局指标
主要结局
The outcome is mainly assessed by clinical symptom, scoring HIT- Headache Impact Test questionnaire.
时间窗: 30 days
Reduction in the episode of headache, duration of headache, increase quality of life
时间窗: 30 days
次要结局
- Influence of other co factors related to the disease such as Age, Sex, zodiac sign & stars etc..(Pre study screening and after treatment)