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| Name | Class |
|---|---|
| Ecion Pharmaceutical CO..LTD | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator:Topiramate | Active Comparator | 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. |
|
| Experimental:Danzhen | Experimental | The treatment with Danzhen is 3 tablets triple daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danzhen | Drug |
| ||
| Topiramate |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yajie Wang, MM | Contact | 944759069@qq.com | ||
| Gang Zhao, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, MD | Xijing Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi’an | Shanxi | 710032 | China |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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|
|
| 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 |
| D009422 | Nervous System Diseases |
| Carbohydrates |
| D007661 | Ketoses |