A double-blind, randomized, placebo-controlled trial of individualized homeopathic medicines to treat migraine in adults utilizing Boenninghausen’s hexameter for using Boenninghausen’s Characteristics and Repertory by C.M. Boger
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Migraine Disability Assessment questionnaire (MIDAS)
研究概览
简要总结
Migraine episodes last 4-72 hours, often with moderate to severe one-sided, pulsating headaches, worsened by physical activity, and accompanied by phonophobia, photophobia, nausea, or vomiting. Global migraine prevalence has risen significantly over the past three decades, from 721.9 million in 1990 to 1.1 billion in 2019, and is now the second leading cause of neurological disability-adjusted life-years. Homeopathy is frequently used therapy to treat migraine , however the research evidence is limited. . The systematic approach to analysis, evaluation, and totality framing using Boenninghausen’s Characteristics and Repertory (BCR) is not clearly outlined in the available literature. Within the chapter choosing the remedy, Dr Boger “shows how the final differentiation depends upon the individualistic or peculiar symptoms. A truly scientific procedureâ€. He outlines seven key points for remedy selection, which are also explained in Boenninghausen’s Lesser Writings under the hexameter. In this study, these hexameter points will consistently be used to frame totality during repertorization for all cases treated with BCR. This 3 months, double-blind, randomized, placebo-controlled is aimed at evaluating the efficacy of homeopathic medicines in the treatment of migraine in 99 adults. The primary outcome measure is MIDAS, measured at baseline and after 3rd month; the secondary outcomes are SF-36, MYMOP-2 questionnaires, all measured at baseline, and every month, up to 3 months. Comparative analysis will be measured to detect group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age group 18-50 years.
- •Either sex or transgender.
- •Patients having migraine (ICD 10 code G43) as per the criteria of International Classification of Headache Disorders (ICHD-3) for migraine.
- •Migraine with aura a.
- •Headache attacks lasting 4 to 72 hours (untreated or unsuccessfully treated) b.
- •Headache has at least 2 of the following characteristics: i.
- •Unilateral location ii.
- •Pulsating quality iii.
- •Moderate-to-severe pain intensity iv.
- •Aggravation by or causing avoidance of routine physical activity (walking or climbing stairs) c.
- •During a headache, at least 1 of the following: i.
- •Nausea and/or vomiting ii.
- •Photophobia and phonophobia II.
- •1 or more of the fully reversible aura symptoms mentioned below: i.
- •Sensory iii.
- •Speech and language iv.
- •Brainstem vi.
- •At least 2 of the characteristics mentioned below: i.
- •At least 1 aura symptom spreads gradually over 5 or more minutes ii.
- •Each aura symptom lasts 5 to 60 minutes iv.
- •At least 1 aura symptom is unilateral v.
- •At least 1 aura symptom is positive vi.
- •The aura is accompanied, or followed within 60 minutes, by the headache III.
- •On 8 days or more per month for more than 3 months, fulfilling any of the below mentioned criteria: 9 a.
- •Criteria Ib and Ic: For migraine without aura b.
- •Criteria IIa and IIb: For migraine with aura c.
- •Believed by the patient to be migraine headaches at onset and relieved by triptan or ergot derivative
- •Patients with ability to understand English/ Hindi/ Bengali.
排除标准
- •Denying informed consent.
- •Patient suffering from little or no disability (MIDAS Score less than or equal to 20) and severe disability (MIDAS Score more than or equal to 20) from migraine.
- •An acute, severe headache, particularly if it is the first or worst episode and there has been a noticeable shift in the frequency or pattern of headaches.
- •Abnormal neurologic examination, particularly in cases when there are unidentified indications or symptoms (e.g., stiff neck, confusion, papilledema, epilepsy).
- •New episodes in immunocompromised or elderly patients (more than 50 years of age)..
- •Signs or symptoms that are meningeal or systemic e.g. fever, weight loss, exhaustion.
- •Pain that lasts longer than 72 hours.
- •Pregnancy, nursing mothers, and puerperal women.
- •Chewing tobacco, smoking, alcoholism, substance misuse in any form, and/or dependence (TAPS tool).
- •Receiving homoeopathic treatment for a chronic illness all through the previous three months.
- •Simultaneously taking part in any other clinical trial.
结局指标
主要结局
Migraine Disability Assessment questionnaire (MIDAS)
时间窗: Baseline and after 3rd month
次要结局
- 36-Item Short Form Health Survey questionnaire (SF-36)(Baseline and every month up to 3 months)
- Measures Yourself Medical Outcome Profile version 2 questionnaire (MYMOP-2)(Baseline and every month up to 3 months)
研究者
Priyanka Sen
D N De Homoeopathic Medical College and Hospital
