Is Yokukansan effective for treatment of medication overuse headache?

JRCT ID: jRCTs031180275

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Medication Overuse Headache
• Date of first enrollment: 08/12/2015
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Taking yokukansan or placebo for 8 weeks

Outcome(s)

Primary Outcome

Number of headache days
Number of migraine attacks

Secondary Outcome

Intensity of headache(VAS score)
Intensity of anxiety(Hamilton AnxietyScale)
Intensity of irritation
HIT6
Questionnaire for Kanpo Medicine
Number of tablets for acute medicine
Laboratory test
Side effect

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients diagnosed as MOH based on ICHD-3 beta criteria
Major headache type should be migraine
Serum potassium level before the start of treatment within 4 weeks should be in normal range
Patients should be more than 20 years old

Exclude criteria

Experience of taking yokukansan
Taking other Kampo-medicine
Having severe cardiac disease, liver disease, kidney disease, hematologic disorders, lung disease, or other severe disease related to life itself
Having psychological disorders such as depression or other disorders due to DSM-5
Under treatment of acupuncture, chiropractic, massage
Being pregnant or giving milk to the baby and hoping to be pregnant

Related Information

• Primary Sponsor: Mitsufuji Takashi
• Secondary Sponsor: Araki Nobuo
• Source(s) of Monetary Support: Japan Agency Medical Research and Development
• Secondary ID(s): UMIN000018148