Efficacy of Individualized Homeopathic Remedies on Migraine: a Randomized, Triple-blind, Placebo Controlled Study.

Last updated: July 18, 2022
Sponsor: Hospital General de Agudos Bernardino Rivadavia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Migraine (Adult)

Pain

Treatment

N/A

Clinical Study ID

NCT05468801
136/18
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with certified diagnosis of migraine with or with out aura of at least oneyear of evolution according to the Subcommittee of Headaches Classification of theInternational Headache Association 3rd edition (ICHD-III)
  • Patients receiving acute or preventive standardized pharmacological treatment formigraine for at least one year prior to study inclusion
  • Patients do not have chronic migraine defined as Headache occurring on 15 or more daysper month for more than 3 months, which has the features of migraine headache on atleast 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 standardizedcontraceptive method
  • Participants who are able to maintain a prospectively collected simple headache diary

Exclusion

Exclusion Criteria:

  • Patients under standardized pharmacological treatment who have significantly (>50%)added or modified migraine preventive drugs doses within 3 months prior to studybaseline
  • Patients who have initiated or significantly (>50%) modified doses of any drug for anychronic 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 vasculardisorders, non vascular intracranial lesions, abuse of alcohol or other psychoactivesubstances.
  • Pregnant or probably pregnant patients according to date of last menstruation referredby the patient of more than 35 days in women with regular cycles or plasma betasub-unit of human chorionic gonadotrophin in women with irregular menstrual cycles
  • Patients with history of anaphylaxis, non controlled diabetes, severe disorders beingneurological, cardiac, pulmonary and/or hepatic as well as psychosis or suicideideation and/or attempts.
  • Patients with other acute or chronic pain disorders, history of hemiplegic migraine ormigraine 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 Similitudedefined as an homeopathic previous success probability for the selected homeopathicremedy of of 5 to 7 points in a probability scale of 1 to 7
  • NOTE: Please contact the investigator for additional information aboutHomeopathic criteria

Study Design

Total Participants: 72
Study Start date:
March 01, 2019
Estimated Completion Date:
November 01, 2023

Study Description

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.

Connect with a study center

  • Hospital Bernardino Rivadavia

    Buenos Aires, 1425
    Argentina

    Active - Recruiting

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