Efficacy and Safety of Danzhen

Phase 1

• Conditions: Migraine
• Interventions: Drug: Danzhen; Drug: Topiramate

• Registration Number: NCT02645370
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Study First Posted: 2016-01-01
• Last Update Posted: 2016-01-01
• Study Start: 2016-02
• Primary Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental:Danzhen	Danzhen	The treatment with Danzhen is 3 tablets triple daily.
Active Comparator:Topiramate	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.

Primary Outcome Measures

Name	Time	Method
A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs.	at baseline phase/the third treatment month of maintenance phase

Secondary Outcome Measures

Name	Time	Method
The decrease of numbers of rescue medication doses used/month	at baseline phase/the third treatment month of maintenance phase
The decrease of disability days of migraine/month	at baseline phase/the third treatment month of maintenance phase
The percentage of discontinued the drug because of side effects	at the third treatment month of maintenance phase
A 30% or greater reduction in headache time	at baseline phase/the third treatment month of maintenance phase
Compliance	at the third treatment month of maintenance phase
Beck Depression Inventory (BDI) scores	at the third treatment month of maintenance phase

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shanxi, China