To compare the effectiveness of individualised homoeopathic medicine versus Chionanthus virginica mother tincture in management of migraine-A single Blind Randomised controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To evaluate which is more effective i.e., individualized homoeopathic medicine or Chionanthus virginica mother tincture in management of migraine.
研究概览
简要总结
Migraine is a disabling primary headache disorder characterized by attacks of unilateral throbbing headache, associated with photophobia, phonophobia, nausea, vomiting, or movement sensitivity, which may last for 4 to 72 hrs.
HYPOTHESIS:
• NULL HYPOTHESIS : There is no significant difference between the two comparable groups i.e. individualized HOMOEOPATHIC MEDICINE group and CHIONANTHUS VIRGINICA mother tincture group in management of migraine.
• ALTERNATIVE HYPOTHESIS : There is significant difference between two comparable groups i.e., individualized HOMOEOPATHIC MEDICINE group VERSUS CHIONANTHUS VIRGINICA mother tincture group in management of migraine.
- PRIMARY OBJECTIVE
 To evaluate which is more effective i.e., individualized homoeopathic medicine or Chionanthus virginica mother tincture in management of migraine.
 To assess the improvement of patient in terms of frequency of attack and severity of symptoms of migraine.
- SECONDARY OBJECTIVE
 To assess the improvement in quality of life by using MIDAS SCALE.
This study will be a prospective, parallel group, single blind, randomized controlled trial. simple random sampling will be used where patient will be randomly allocated in 1:1 ratio into 2 groups.individualized homoeopathic medicine treatment group or chionanthus virginica mother tincture treatment group. Patient recruitment will be done from OPD of NHMC&H . 60 clinical cases of migraine will be taken as sample size of this study. Duration of study is of 1 year. Basis of prescription is a complete case taking and repertorisation will be done according to the homoeopathic principles. In case of individualized homoeopathic medicine , prescription will be based on analysis , evaluation and individualization of case. selection of potency and dosage will be based upon the severity of symptoms, susceptibilty of patient. Mode of administration will be oral. frequency of repetition depend upon the severity of symptoms, and as per the need and necessity of case preferably fortnight or monthly. final evaluation of results will be based on the basis of improvement in symptoms as well as by using Midas scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients giving informed consent.
- •2.Have a history of migraine as defined by the International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2006) of at least 1 year prior to enrollment, migraine onset prior to age 50, and a moderate frequency of migraine headaches 3.Have clinical laboratory test results within normal reference ranges or, if outside the normal range, judged not clinically significant by the Investigator 4.Must not be on any migraine prevention therapy, including botulinum toxin (Botox) 5.Agree not to post any personal medical data related to the study or information related to the study on any website or social media site (for example, Facebook, Twitter, et cetera) until the trial has completed.
排除标准
- •1.Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device, or concurrent enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •2.History of chronic migraine or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine.
- •3.History of headache (for example, cluster headache or Medication Overuse Headache [MOH]) other than migraine or tension type headache as defined by IHS ICHD-II within 12 months prior to randomization.
- •4.Diagnosed cases of psychiatric illness.
- •5.Pregnant women and lactating mothers.
- •6.Excessive alcohol, opiate, or barbiturate use; history of drug abuse or dependence.
- •7.Patients who are terminally ill, under immunosuppressive treatment or self-reported immunocompromised state.
- •8.Unwilling to take part and not giving consent to join the study or unable to read patient information sheet.
结局指标
主要结局
1.To evaluate which is more effective i.e., individualized homoeopathic medicine or Chionanthus virginica mother tincture in management of migraine.
时间窗: Initially at baseline and then fortnightly or monthly preferably up to one year.
2.To assess the improvement of patient in terms of frequency of attack and severity of symptoms of migraine.
时间窗: Initially at baseline and then fortnightly or monthly preferably up to one year.
次要结局
- 1.To assess the improvement in quality of life by using MIDAS SCALE.(Intially at baseline and then once in three months upto one year.)
研究者
Dr Aiswarya Mohan
Nehru Homoeopathic Medical College And Hospital