Migraine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients who meet the diagnostic criteria for "migraine" in the *International Classification of Headache Disorders (ICHD-III)*, including "migraine without aura" and "migraine with aura." The specific diagnostic criteria are as follows: (1.1) Migraine without aura: A. Headaches that meet criteria B-D occur at least 5 times. B. Headache episodes last 4-72 hours (untreated or ineffectively treated). C. At least 2 of the following 4 characteristics: 1) Unilateral (one-sided) location; 2) Pulsating quality; 3) Moderate or severe intensity; 4) Aggravation by or inability to perform routine physical activity (e.g., walking or climbing stairs). D. During the attack, at least 1 of the following 2: 1) Nausea and/or vomiting; 2) Photophobia and phonophobia. E. Cannot be better explained by another ICHD-III diagnosis. (1.2) Migraine with aura: A. At least 2 attacks meet criteria B and C. B. At least 1 fully reversible aura symptom, which may be: 1) Visual; 2) Sensory; 3) Speech and/or language; 4) Motor; 5) Brainstem; 6) Retinal. C. At least 3 of the following 6 characteristics: 1) At least 1 aura symptom lasts more than 5 minutes; 2) Two or more symptoms occur in succession; 3) Each individual aura symptom lasts 5-60 minutes; 4) At least 1 aura symptom is unilateral; 5) At least 1 aura symptom is positive (e.g., flashes of light); 6) Headache occurs during the aura or within 60 minutes of its onset. D. Cannot be better explained by another ICHD-III diagnosis. (2) Patients who meet the diagnostic criteria for both migraine without aura and migraine with aura, and have a history of multiple attacks of migraine with a prodrome. Prodromal symptoms may include but are not limited to: A. Gastrointestinal symptoms: nausea, vomiting, bloating, hunger, etc. B. Sensory symptoms: dizziness, photophobia, phonophobia, etc. C. Neurological and psychological symptoms: difficulty concentrating, excitability, irritability, etc. D. General symptoms: fatigue, frequent yawning, neck stiffness, etc. (3) Patients aged 18-75 years, of any gender, with a BMI <40 kg/m², who voluntarily participate in this study and sign the "Informed Consent Form." (4) Patients with good compliance and excellent communication skills. (5) Patients with a history of migraine lasting more than 3 months, with at least 2 episodes per month. (6) Patients whose migraine treatment regimen has been stable for 1 month with no significant changes. (7) Patients who can distinguish prodromal symptoms associated with migraine from similar symptoms unrelated to migraine.
Exclusion criteria
Exclusion criteria: (1) Patients with severe cardiovascular, cerebrovascular, kidney, liver, gastrointestinal, endocrine, or nervous system diseases; (2) Patients with a history of hemiplegia or migraines; (3) Patients with cognitive impairments or mental illnesses who are unable to cooperate with treatment or medical history collection; (4) Patients who are pregnant, breastfeeding, or planning to conceive; (5) Patients with tension-type headaches lasting more than 10 days per month; (6) Patients with a history of allergies or adverse reactions to related Chinese herbal medicines; (7) Patients who have participated in other drug clinical studies in the past six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of migraine attacks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Headache Duration;Numerical Pain Rating Scale;Headache Impact Test;Migraine Disability Assessment Questionnaire;Traditional Chinese Medicine (TCM) Syndrome Efficacy; | — |
Countries
China
Contacts
Beijing Massage Hospital