None listed
Conditions
Interventions
Drug : Participants who met the inclusion criteria are randomised to experimental group(Jodeung-San extract granule group) or control group(placebo group).
Experimental group: Jodeung-San extract gran
Sponsors
Wonkwang University, Gwangju Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females aged 19 to 75 years old diagnosed with migraine by the third-bata edition of the International Classification of Headache Disorders(ICHD-3 beta version) of the International Headache Society. 2) Those who can communicate sufficiently with the researcher and write the questionnaire and headache diary. 3) Non-pharmacological prophylactic drugs which have been taken at least one month prior to treatment can continue during the study. 4) Agreed with written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Those who took the following medications that can affect headache within 4 weeks of the screening visit: Tricyclic antidepressants, monoamine oxidase inhibitors, high-dose magnesium (> 100 mg / d), corticosteroids, topical anesthetics, botulinum toxin, etc. 2) Those who with ischemic heart disease. 3) Those who with liver or kidney function disorder: exceeds the normal limit by more than two times in AST, ALT or exceeds the normal limit in creatinine. 4) Those who have trouble with normal Korean language communication. 5) Those who have a psychiatric disorder that can not follow this study compliance. 6) Those who have a history of drug or alcohol abuse. 7) Patients with cancer, immunosuppressed patients. 8) Female patients who are pregnant or breastfeeding , patients with positive findings in the urine pregnancy test before random assignment, patients who are unable or unwilling to use appropriate contraceptive methods (hormonal contraceptives, condoms, intrauterine devices, etc.) to avoid pregnancy throughout the entire trial period. 9) Those who participate in other clinical studies. 10) Those who were considered as unsuitable for participation by the researcher .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Headache attack days (HAD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Headache Impact Test(HIT);Migraine Specific Quality of Life (MSQoL);Deficiency-Excessiveness-Cold-Heat Questionnaire, Blood Stasis Questionnaire;Economic evaluation, Patient Satisfaction Evaluation;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactJihye Seo
Wonkwang University, Gwangju Medical Center
Outcome results
None listed