Efficacy and Safety of Danzhen

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02645370

Enrollment

3300

Registered

2016-01-01

Start date

2016-02-29

Completion date

Unknown

Last updated

2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, Danzhen, Topiramate, Headache diary APP, preventive treatment

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-worldsetting.Patients are asked to maintain a detailed headache diary via headache diary APP throughout the treatment period.

Interventions

DRUGDanzhen

DRUGTopiramate

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The decrease of numbers of rescue medication doses used/month	at baseline phase/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
The decrease of disability days of migraine/month	at baseline phase/the third treatment month of maintenance phase
Beck Depression Inventory (BDI) scores	at the third treatment month of maintenance phase
Compliance	at 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

Countries

China

Contacts

Primary ContactYajie Wang, MM

944759069@qq.com

Backup ContactGang Zhao, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026