Clinical trial NCT02645370: Efficacy and Safety of Danzhen
Official title: Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective "Real-World" Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Migraine
Keywords: Migraine
Danzhen
Topiramate
Headache diary APP
preventive treatment
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Ecion Pharmaceutical CO..LTD
First posted: 2016-01-01
Enrollment: 3300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients older than or equal to 18 years and less than 70 years.
* The diagnosis of migraine is made according to 2004 The International Classification of Headache Disorders: 2nd edition (ICHD-II) .
* Consent form signed by the participant or his/her authorized surrogate.

Exclusion Criteria:

* Patients had primary or secondary headache disorders other than migraine.
* Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning apregnancy in the next year or if they were not using an adequate form of birth control.
* Patients will be excluded if they had significant medical or psychiatric disease,or taking another antidepressant for any reason and not able to discontinue.
* Patients used other preventive pharmacological agents during the 1 month prior to baseline period.

Primary outcomes:
measure: 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.
timeFrame: at baseline phase/the third treatment month of maintenance phase
Secondary outcomes:
measure: The decrease of disability days of migraine/month
timeFrame: at baseline phase/the third treatment month of maintenance phase
measure: The decrease of numbers of rescue medication doses used/month
timeFrame: at baseline phase/the third treatment month of maintenance phase
measure: A 30% or greater reduction in headache time
timeFrame: at baseline phase/the third treatment month of maintenance phase
measure: The percentage of discontinued the drug because of side effects
timeFrame: at the third treatment month of maintenance phase
measure: Beck Depression Inventory (BDI) scores
timeFrame: at the third treatment month of maintenance phase
measure: Compliance
timeFrame: at the third treatment month of maintenance phase
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shanxi
Study officials:
affiliation: Xijing Hospital
name: Gang Zhao, MD
role: STUDY_DIRECTOR
References: