A RANDOMIZED CLINICAL TRIAL ON THE EFFICACY OF SIRAVEDHA AND KUMKUMADI GHRITA NASYA ALONG WITH CHANDRAKANTA RASA ORALLY IN ARDHAVABHEDAKA W. S. R. TO MIGRAINE
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in clinical manifestation of Ardhawbhedak w.s.r.to migraine
研究概览
简要总结
This trial will be done to compare clinical efficacy ofSiravedha and Kumkumadi Ghrit Nasya along with Chandrakant Rasa inArdhawbhedaka wsr to Migraine. This is an interventional, Open clinical trial.The sample size is 30 with 2 groups, each group having a sample size of 15patients. In group A Kumkumadi Ghrita Nasya and chandrakant Rasa will begiven. 1 Tablets of 125 mg twice a day after food (250 mg/day) withwater for 7 days and 8-10 drop of Nasya for 7 day and again for 7 days with 7days gape, should be given. Duration of trial is 21 days. In groupB Siravedha done andchandrakant Rasa will be given. 1 Tablets of 125 mg of Chandrakant Rasagiven orally twice a day after food (250mg/day) with water for 7 days andSiravedha done once a week for two sittings. Duration of trial is 14 days. Theassessment of the clinical response in the total number of patients will bemade on subjective and objective parameters. Objective parametersinclude Laboratory Investigations:- CBC, RBS, ESR, LFT ,RFT , Fundusexamination, Vision test by snellens chart and refraction, IOP, CT, BT, HIV,HbsAg, X Ray PNS. Duration of Study will be 60 days (21 days trial+60 days follow up). Follow up for 2 months at 15 days interval aftercompletion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to participate in this trial through written informed consent.
- •2.Patients between18 to 55 years of age from either sex.
- •3.Patients presenting with symptoms of Ardhavabhedaka/ Migraine described as per Ayurveda and modern science.
排除标准
- •1.Secondary headaches caused by meningitis, tumors, encephalitis, head and neck trauma, trigeminal neuralgia, cervical spondylitis, refractive errors, sinusitis and other disorders of cranium, neck, eyes, ears, nose, sinuses, teeth etc.
- •2.Patients with complicated Migraine like status migrainosus, hemiplegic migraine and having any chronic debilitating disease with other neurological pathology.
- •3.Pregnant and lactating women.
- •4.Patients suffering from any other major systemic disorders e.g. tuberculosis, cancer, heart disease etc.
- •Patients unfit for Siravedha such as patients with hemorrhagic diseases (e.g. hemophilia), anaemia, hypotension, severe allergic diathesis and on anticoagulant treatment.
结局指标
主要结局
Changes in clinical manifestation of Ardhawbhedak w.s.r.to migraine
时间窗: 21 days
次要结局
- Changes in parameters of ardhawbhedak w.s.r.to Migraine(60 days.)