Efficacy of Individualized Homeopathic Remedies on Migraine: a Randomized, Triple-blind, Placebo Controlled Study. (HOMEOMIG)
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine, Homeopathy, Individualized, Triple blind, Randomized, Clinical trial, headache
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hospital Bernardino RivadaviaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Individualized Homeopathic Remedy plus Standard Pharmacologic Treatment
Placebo plus Standard Pharmacologic Treatment
Each subject receives an individually selected homeopathic remedy (individualized homeopathic remedy) as an add on to the conventional standardized pharmacological treatment he/she is receiving prior and during study. Standardized pharmacological treatment will be monitored and approved at first hospital neurological visit and as a requirement needs to be unchanged within 3 months prior inclusion and throughout the study.
Subjects receive an indistinguishable placebo plus the conventional standardized pharmacological treatment he/she is receiving prior and during study. Standardized pharmacological treatment will be monitored and approved at first hospital neurological visit and as a requirement needs to be unchanged within 3 months prior inclusion and throughout the study.