Efficacy and Safety of Danzhen

NCT ID: NCT02645370

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 3300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Active Comparator:Topiramate

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.

Group Type: ACTIVE_COMPARATOR

Topiramate

Intervention Type: DRUG

Experimental:Danzhen

The treatment with Danzhen is 3 tablets triple daily.

Group Type: EXPERIMENTAL

Danzhen

Intervention Type: DRUG

Interventions

Danzhen

Intervention Type: DRUG

Topiramate

Intervention Type: DRUG

Other Intervention Names

TPM

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecion Pharmaceutical CO..LTD

UNKNOWN

Sponsor Role: collaborator

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Zhao, MD

Role: STUDY_DIRECTOR

Xijing Hospital

Locations

Xijing Hospital

Xi’an, Shanxi, China

Countries

China

Central Contacts

Yajie Wang, MM

Role: CONTACT

944759069@qq.com

Gang Zhao, MD

Role: CONTACT

Other Identifiers

Xijing-APP-CER

Identifier Type: -

Identifier Source: org_study_id