The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.
In adults between 18- and 65-years in China,the prevalence of migraine is 9.3% in general. Migraine is a heterogeneous condition that may produce a range of symptom profiles and various degrees of disability.The disability resulting from migraine can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using topiramate as the control, is to evaluate the effectiveness and safety of Danzhen for the prophylaxis of migraine in a "real-world"setting.Patients are asked to maintain a detailed headache diary via headache diary APP throughout the treatment period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,300
Xijing Hospital
Xi’an, Shanxi, China
A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs.
Time frame: at baseline phase/the third treatment month of maintenance phase
The decrease of disability days of migraine/month
Time frame: at baseline phase/the third treatment month of maintenance phase
The decrease of numbers of rescue medication doses used/month
Time frame: at baseline phase/the third treatment month of maintenance phase
A 30% or greater reduction in headache time
Time frame: at baseline phase/the third treatment month of maintenance phase
The percentage of discontinued the drug because of side effects
Time frame: at the third treatment month of maintenance phase
Beck Depression Inventory (BDI) scores
Time frame: at the third treatment month of maintenance phase
Compliance
Time frame: at the third treatment month of maintenance phase
Gang Zhao, MD
CONTACT
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