NCT02645370

Efficacy and Safety of Danzhen

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3,300 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Danzhen
DRUG	Topiramate

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-07-01
• First posted: 2016-01-01
• Last updated: 2016-01-01

Locations

1 site across 1 country: China