Efficacy and Safety of Danzhen

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 1

Conditions: Migraine

Treatments: Drug: Topiramate; Drug: Danzhen

Study type: Interventional

Funder types: Other

Identifiers

NCT02645370

Xijing-APP-CER

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,300 participants in 2 patient groups

Active Comparator:Topiramate

Active Comparator group

Description:

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.

Treatment:

Drug: Topiramate

Experimental:Danzhen

Experimental group

Description:

The treatment with Danzhen is 3 tablets triple daily.

Treatment:

Drug: Danzhen