Evaluating the effectiveness of Individualized Homoeopathic Medicines vs Iris Versicolor in treatment of Migraine: A randomised controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of Individualized Homoeopathic Medicines vs Iris versicolor in reducing the intensity(VAS) and frequency(attacks per month) of Migraine among the participants.
研究概览
简要总结
This study is a Randomized controlled clinical trial involving patients aged 18 to 60 years who present with migraine symptoms, as defined by the International Classification of Headache Disorders, 3rd edition (ICHD-III). Participants will be divided into two groups through randomization. One group will receive Individualized homeopathic remedy, while the other group will be administered Iris Versicolor. The potency, dosage and repetition of the medicines will be determined on the basis of the requirement of case, following the homeopathic principles.
Participants will be followed up every two weeks, with assessments conducted at each visit. The Visual Analog Scale (VAS) for pain will be measured at every 2 weeks, while the frequency of migraine attacks will be recorded monthly. The Migraine Disability Assessment (MIDAS) will be evaluated at baseline and after six months of treatment. Each case will be observed for a minimum period of six months, and the data collected at the end of this period will be statistically analyzed and interpreted in comparison to baseline values to draw inferences.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Both sexes of age group 18-60 years, irrespective of their race, caste, religion and socioeconomic status.
- •2.Patients presenting with symptoms of migraine according to International Classification of Headache Disorder 3rd edition (ICHD-III).
排除标准
- •Patients suffering with any cause of secondary headache like trauma, metabolic or vascular disorders, non-vascular intracranial lesions, abuse of alcohol or other psychoactive substances.
- •Pregnant and lactating mothers.
- •Migraine patients suffering from any life-threatening complication.
- •Patients with history of cerebral-vascular accident, convulsions, severe coronary disease, uncontrolled hypertension, and malignancy.
- •Patients with psychiatric comorbidities.
- •Unwilling to take part and not giving consent to join the study or unable to read the patient information sheet.
- •Patients unable to comply with study protocol.
结局指标
主要结局
To compare the effectiveness of Individualized Homoeopathic Medicines vs Iris versicolor in reducing the intensity(VAS) and frequency(attacks per month) of Migraine among the participants.
时间窗: The Visual Analog Scale (VAS) for pain will be measured at baseline and then at every 2 weeks, till 6 months(24th week) of treatment while the frequency of migraine attacks will be recorded at baseline and then at every 4 weeks, till 6 months(24th week) of treatment.
次要结局
- To evaluate the effectiveness of Individualized Homoeopathic Medicines compared to Iris versicolor on migraine-related disability using the Migraine Disability Assessment (MIDAS) score as the outcome measure.(The Migraine Disability Assessment (MIDAS) will be evaluated twice in this study. First at baseline & then after six months(24th week) of treatment.)
研究者
Dr Manisha Gairola
Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Delhi-110021