Back to resultsEfficacy and Safety of Danzhen
Primary Purpose
Migraine
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Danzhen
Topiramate
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring Migraine, Danzhen, Topiramate, Headache diary APP, preventive treatment
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.
Sites / Locations
- Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active Comparator:Topiramate
Experimental:Danzhen
Arm Description
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.
The treatment with Danzhen is 3 tablets triple daily.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The decrease of disability days of migraine/month
The decrease of numbers of rescue medication doses used/month
A 30% or greater reduction in headache time
The percentage of discontinued the drug because of side effects
Beck Depression Inventory (BDI) scores
Compliance
Full Information
NCT ID
NCT02645370
First Posted
December 30, 2015
Last Updated
December 30, 2015
Sponsor
Xijing Hospital
Collaborators
Ecion Pharmaceutical CO..LTD
1. Study Identification
Unique Protocol Identification Number
NCT02645370
Brief Title
Efficacy and Safety of Danzhen
Official Title
Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective "Real-World" Study.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Ecion Pharmaceutical CO..LTD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Danzhen, Topiramate, Headache diary APP, preventive treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator:Topiramate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental:Danzhen
Arm Type
Experimental
Arm Description
The treatment with Danzhen is 3 tablets triple daily.
Intervention Type
Drug
Intervention Name(s)
Danzhen
Intervention Type
Drug
Intervention Name(s)
Topiramate
Other Intervention Name(s)
TPM
Primary Outcome Measure Information:
Title
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.
Time Frame
at baseline phase/the third treatment month of maintenance phase
Secondary Outcome Measure Information:
Title
The decrease of disability days of migraine/month
Time Frame
at baseline phase/the third treatment month of maintenance phase
Title
The decrease of numbers of rescue medication doses used/month
Time Frame
at baseline phase/the third treatment month of maintenance phase
Title
A 30% or greater reduction in headache time
Time Frame
at baseline phase/the third treatment month of maintenance phase
Title
The percentage of discontinued the drug because of side effects
Time Frame
at the third treatment month of maintenance phase
Title
Beck Depression Inventory (BDI) scores
Time Frame
at the third treatment month of maintenance phase
Title
Compliance
Time Frame
at the third treatment month of maintenance phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yajie Wang, MM
Email
944759069@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Zhao, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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Efficacy and Safety of Danzhen
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