Efficacy and Safety of Danzhen

Study Overview
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Brief Summary
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The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a real-world setting.

Detailed Description
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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-worldsetting.Patients are asked to maintain a detailed headache diary via headache diary APP throughout the treatment period.

Official Title
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Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective Real-World Study.

Conditions
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Migraine

Intervention / Treatment
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* Drug: Danzhen
* Drug: Topiramate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator:Topiramate<br>The treatment with TPM is initiated at a 50 mg daily dose and sequentially increase every 7 days, as tolerated, in 25 mg increments up to a target dose of 150 mg total/day. | Drug: Topiramate<br> <br> * Other names: TPM;|
| Experimental: Experimental:Danzhen<br>The treatment with Danzhen is 3 tablets triple daily. | Drug: Danzhen<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | at baseline phase/the third treatment month of maintenance phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease of disability days of migraine/month |  | at baseline phase/the third treatment month of maintenance phase | 
| The decrease of numbers of rescue medication doses used/month |  | at baseline phase/the third treatment month of maintenance phase | 
| A 30% or greater reduction in headache time |  | at baseline phase/the third treatment month of maintenance phase | 
| The percentage of discontinued the drug because of side effects |  | at the third treatment month of maintenance phase | 
| Beck Depression Inventory (BDI) scores |  | at the third treatment month of maintenance phase | 
| Compliance |  | at the third treatment month of maintenance phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Danzhen, Topiramate, Headache diary APP, preventive treatment