Randomized, Triple-blind, Placebo Controlled Study to Evaluate the Efficacy of Individualized Homeopathic Remedies With High Grade of Pathological Similarity vs Conventional Standardized Pharmacological Treatment in Patients With Migraine.
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Number of migraine days
研究概览
简要总结
Migraine, a chronic and often lifelong neurological disorder, is the second leading cause of years lived with disability worldwide. To reduce this global burden, concerted efforts are needed to implement and improve migraine health-care policies. Several observational studies showed significant improvement of different headaches types with homeopathy. The purpose of this study is the assessment of the efficacy of Individualized Homeopathic Remedies (specific remedies for each patient) versus Conventional pharmacological treatment in patients with migraine.
详细描述
This is a randomized, triple-blind, placebo-controlled, parallel group study in adult subjects with diagnosis of migraine with or without aura. All patients will be assessed in a screening visit at the Study Hospital Dept. of Neurology in order to confirm and certify migraine diagnosis and evaluate correctness and stability of usual acute and preventive standardized pharmacological treatment. Patients will fulfill a 30 day baseline period to monitor headache activity, migraine related symptoms, and medication usage. Subjects agreeing to participate in the study and meeting clinical-neurological eligibility criteria will then assist to a first homeopathic consultation to assess viability of homeopathic treatment and selection of the individualized homeopathic remedy. Patients who meet both neurological and homeopathic inclusion criteria will begin a three month treatment phase. An estimated of 72 patients, calculated according to the Open-Epi program ((c) 2003, 2008 Andrew G. Dean and Kevin M. Sullivan, Atlanta, GA, USA) , will be randomized according to statistics Epidat Program (4.2 version, july 2016 Panamerican Health Organization (PHO-WHO); to receive Individualized homeopathic treatment + standard pharmacological treatment OR unidentified placebo + standard pharmacological treatment. Study homeopathic remedy or placebo will be administered for a minimum period of 12 weeks with control visits every 4 weeks to assess neurological and homeopathic evolution, adherence and possible adverse events. During the study period patients will continue filling the migraine diary collecting frequency, length and type of headaches, acute medication usage and migraine associated symptoms. At the end of treatment, a final clinical homeopathic visit will take place as well as a final Neurological visit at study Hospital. Hospital visits are independent of clinical visits and performed by different study physicians.
After conclusion of treatment phase patients will have three more follow up visits for the assessment of clinical and homeopathic evolution, possible adverse events and general satisfaction with the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Remedy vials will be filled according randomized allocation in 2 number sets; one for the experimental group and two for the control group. Randomization information will be kept by the Study pharmaceutical responsible who will be the only person in possession of the sequence from the beginning of the study. Only the pharmaceutical responsible will have access to the randomization codes during the study and only in case of clinical emergency can break the code of an individual patient. The pharmaceutical responsible will never have any direct nor indirect contact with the study subjects. The The study statistician/s will be masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with certified diagnosis of migraine with or with out aura of at least one year of evolution according to the Subcommittee of Headaches Classification of the International Headache Association 3rd edition (ICHD-III)
- •Patients receiving acute or preventive standardized pharmacological treatment for migraine for at least one year prior to study inclusion
- •Patients do not have chronic migraine defined as Headache occurring on 15 or more days per month for more than 3 months, which has the features of migraine headache on at least 8 days per month (ICHD-III)
- •Patients meeting ICHD-III criteria of probable medication overuse headache (MOH)
- •Female patients in reproductive age that are correctly using a standardized contraceptive method
- •Participants who are able to maintain a prospectively collected simple headache diary
排除标准
- •Patients under standardized pharmacological treatment who have significantly (>50%) added or modified migraine preventive drugs doses within 3 months prior to study baseline
- •Patients who have initiated or significantly (>50%) modified doses of any drug for any chronic treatment with any agent with proven analgesic action or psychiatric action (antidepressants, antipsychotics, mood stabilizers, etc) or neurological action (anticonvulsivants, antiparkinsonians, etc) within 3 months prior to study baseline
- •Patients suffering any cause of secondary headache like trauma, metabolic or vascular disorders, non vascular intracranial lesions, abuse of alcohol or other psychoactive substances.
- •Pregnant or probably pregnant patients according to date of last menstruation referred by the patient of more than 35 days in women with regular cycles or plasma beta sub-unit of human chorionic gonadotrophin in women with irregular menstrual cycles
- •Patients with history of anaphylaxis, non controlled diabetes, severe disorders being neurological, cardiac, pulmonary and/or hepatic as well as psychosis or suicide ideation and/or attempts.
- •Patients with other acute or chronic pain disorders, history of hemiplegic migraine or migraine with brain stem aura, history of cerebral-vascular accident, convulsions, severe coronary disease, non controlled hypertension or cognitive dysfunctions.
- •Patients not meeting homeopathic clinical criteria of High Pathological Similitude defined as an homeopathic previous success probability for the selected homeopathic remedy of of 5 to 7 points in a probability scale of 1 to 7
- •NOTE: Please contact the investigator for additional information about Homeopathic criteria
结局指标
主要结局
Number of migraine days
时间窗: Baseline - Month 3
Assess the efficacy of chosen individualized homeopathic remedy in the preventive treatment of migraine, measuring the change in the number of monthly migraine days comparing baseline to the final month of the 3-month treatment period versus placebo.
Responder in frequency of migraine attacks
时间窗: Baseline - Month 3
Number of subjects achieving diminution in more than 50% of migraine attacks per month comparing baseline to the final month of the 3-month treatment period versus placebo
Number of migraine attacks
时间窗: Baseline - Month 3
Assess the efficacy of chosen individualized homeopathic remedy in the preventive treatment of migraine, measuring the change in the number of weekly migraine attacks comparing baseline to the final month of the 3-month treatment period versus placebo.
Responder in quantity of migraine days
时间窗: Baseline - Month 3
Number of subjects achieving diminution in more than 50% of migraine days per month comparing baseline to the final month of the 3-month treatment period versus placebo
次要结局
- Migraine Specific Quality of Life Questionnaire (MSQ)(Baseline - Month 3)
- Migraine acute medication usage doses(Baseline - Month 3)
研究者
Samuel M. Arrues MD
MD Family Physician
Hospital General de Agudos Bernardino Rivadavia