EFFICACY OF LAGHU SUTASHEKHARA RASA WITH AND WITHOUT BRIHATA DASHMOOLA TAILA NASYA IN THE MANAGEMENT OF MIGRAINE-AN OPEN LABELLED RANDOMIZED COMPARITIVE CLINICAL TRIAL.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in the subjective criteria accessed.
研究概览
简要总结
**Purpose of Research:**Migraine is a neurological and a primary headache disorder. Globally, it is approximated that 15% of people are affected by Migraine. In modern science, number of medicines like anti-inflammatory, pain killer, NSAIDs etc. have been tried in the management of Migraine, but final answer to its management is yet awaited. Moreover, routine use of these drugs leads to GI tract disturbances. So, there is a great scope of research to find out a safe, potent and cost-effective line of treatment through Ayurveda in the management of Migraine.
Information on the Trial procedure and Drug: In Group ALaghu Sutashekhara Rasa, 500 mg, orally with luke warm water, thrice a day after meal for 45 days along with Brihata Dashmoola taila nasya at a dose of 6-6 drops in each nostril at morning (4 sittings, each sitting of 7 days with an interval of 3 days) will be given. **In Group B:**Only Laghu Sutasekhara Rasa, 500 mg, orally with luke warm water, thrice a day after meal for 45 days will be given. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A.
**Description of the process:**In present study, participants who will be clinically diagnosed and confirmed cases of Migraine enlisted in inclusion criteria will be enrolled. All participants will be divided into two groups by computer generated randomization technique having minimum of 15 patients in one group. Group A will be given with Laghu Sutashekhara Rasa, 500 mg orally with luke warm water thrice a day after meal along with Brihata Dashmoola taila nasya (4 sittings, each sitting of 7 days with an interval of 3 days) and Group B will be given only with Laghu Sutashekhara Rasa, 500 mg orally with luke warm water thrice a day after meals, for 45 days.**Follow-up:**After completion of the treatment, the patient will be followed up for 1 month at an interval of 15 days. **Side Effects:**We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. **Results:**The efficacy of the therapy will be asssessed on the basis of subjective criteria. **Benefits:**Project will help us to resolve the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Migraine. Collected information from this research project will be kept confidential, all outcomeswill be noted in tabular form and appropriate tests will be applied to compare the effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients in the age group 18 to 60 years, presenting with signs and symptoms of Migraine.
- •Chronicity of the disease up to 10 years.
- •The diagnosis of the disease shall be done on the basis of clinical manifestations like recurrent attack of headache, mostly unilateral in site, variable in intensity, frequency and duration with or without nausea, vomiting, aura and GI tract symptoms.
排除标准
- •Age less than 18 years and above 60 years.
- •Chronicity of the disease more than 10 years will be excluded.
- •Patients suffering from any chronic debilitating disease, with other neurological pathology, E.N.T. pathology, and cases which require surgical intervention will be excluded from study.
- •Patients suffering from sinusitis, hypertension, secondary headache caused by meningitis, tumour, encephalitis, cervical spondylitis and refractive errors will be excluded from study.
- •Patients using any other systematic drugs which may alter the results of study.
结局指标
主要结局
Reduction in the subjective criteria accessed.
时间窗: 45 days
次要结局
- Prolonged effect of Ayurvedic intervention in the management of Migraine.(45 days)
研究者
Smitha G S
Institute of Teaching and Research in Ayurveda Jamnagar
