A Randomized, Patient-Assessor Double Blind, Placebo-controlled Clinical Trial to Assess Effectiveness and Safety of Jodeung-San Extract Granules(JDS-EX) for Migraine

Wonkwang University, Gwangju Medical Center0 个研究点目标入组 64 人开始时间: 待定最近更新: 2021年12月2日

适应症

试验速览

暂无简介。

•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.

•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 .

发起方

Wonkwang University, Gwangju Medical Center