A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
• Collaborator: Beijing Bionovo Medicine Development Co., Ltd.

Criteria

Inclusion Criteria:

• Must meet the Migraine diagnosis.

• Age of onset should be before age 50 years.

• Migraine must have been occurring for 1 year preceding entry into the trial.

• The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.

• The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.

• Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.

• Ages 18-65.

• Participant can understand and complete the Headache diary.

• All participants signed the informed consent.

Exclusion Criteria:

• Other migraine prophylactic medication is continued 3 months prior to the drug trial.

• Participants who have taken Tianshu capsule during 1 month prior to Screening stage.

• The number of acute treatment for migraine is more than 10 per month.

• Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.

• Participants who abuse alcohol or other drugs.

• Participants who are resistant to all acute migraine drugs prescribed optimally.

• hypotension or uncontrolled hypertension.

• Severe infections.

• Malignancy.

• Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.

• Known allergies or serious side effects with Tianshu capsule in the past.

• Breastfeeding, pregnant and potentially fertile women participant.

• History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.

• Secondary headaches, including hypertension, post-traumatic brain syndrome etc.

• Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.

• Participants who are taking part in other clinical trials.