Efficacy and Safety of Danzhen

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Collaborator: Ecion Pharmaceutical CO..LTD
• Treatments: Topiramate

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.