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

NCT05468801 | Unknown DMC

• 1 other identifier: 136/18
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

Migraine; Homeopathy; Individualized; Triple blind; Randomized; Clinical trial; headache

Outcome Measures

Primary Outcomes (4)

• Number of migraine attacks

  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.

  Baseline - Month 3

• Number of migraine days

  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.

  Baseline - Month 3

• Responder in frequency of migraine attacks

  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

  Baseline - Month 3

• Responder in quantity of migraine days

  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

  Baseline - Month 3

Secondary Outcomes (2)

• Migraine acute medication usage doses

  Baseline - Month 3

• Migraine Specific Quality of Life Questionnaire (MSQ)

  Baseline - Month 3

Study Arms (2)

Individualized Homeopathic Remedy plus Standard Pharmacologic Treatment

EXPERIMENTAL

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.

Other: Individualized Homeopathic Remedy

Placebo plus Standard Pharmacologic Treatment

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Individualized Homeopathic Remedy OTHER

An individualized homeopathic remedy selected for each subject according clinical homeopathic parameters will be administered daily in the form of oral globules as an add on to conventional treatment.

Individualized Homeopathic Remedy plus Standard Pharmacologic Treatment

Placebo OTHER

Placebo plus Standard Pharmacologic Treatment

Placebo plus Standard Pharmacologic Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de Agudos Bernardino Rivadavia: lead
• Hospital Italiano de Buenos Aires: collaborator

Study Sites (1)

Hospital Bernardino Rivadavia

Buenos Aires, 1425, Argentina

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel M Arrues, MD

  Researcher

  STUDY DIRECTOR

Central Study Contacts

Samuel M Arrues, MD

CONTACT

+5411 5805 4524; samuelarrues@yahoo.com

Daniel Gutierrez, MD

CONTACT

+54 11 4416-7477; danielgutierrezbue@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Family Physician

Model Details: Randomized, Triple-blind, Placebo Controlled

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 21, 2022
• Study Start: March 1, 2019
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available 6 months after study termination, for a 12 months period.
• Access Criteria: Data will be shared via e-mail.

Locations

AR (1)