Efficacy and Safety of Danzhen

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02645370
• Other study ID #: Xijing-APP-CER
• Status: Not yet recruiting
• Phase: Phase 1
• First received: December 30, 2015
• Last updated: December 30, 2015
• Start date: February 2016

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: Yajie Wang, MM
• Email: 944759069[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3300
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Danzhen

• Topiramate

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Ecion Pharmaceutical CO..LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The decrease of disability days of migraine/month		at baseline phase/the third treatment month of maintenance phase	No
Secondary	The decrease of numbers of rescue medication doses used/month		at baseline phase/the third treatment month of maintenance phase	No
Secondary	A 30% or greater reduction in headache time		at baseline phase/the third treatment month of maintenance phase	No
Secondary	The percentage of discontinued the drug because of side effects		at the third treatment month of maintenance phase	Yes
Secondary	Beck Depression Inventory (BDI) scores		at the third treatment month of maintenance phase	No
Secondary	Compliance		at the third treatment month of maintenance phase	No