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Efficacy and Safety of Danzhen

This study is not yet open for participant recruitment.
Verified December 2015 by Xijing Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02645370
First Posted: January 1, 2016
Last Update Posted: January 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ecion Pharmaceutical CO..LTD
Information provided by (Responsible Party):
Xijing Hospital
  Purpose
The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.

Condition Intervention Phase
Migraine Drug: Danzhen Drug: Topiramate Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective "Real-World" Study.

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

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. [ Time Frame: at baseline phase/the third treatment month of maintenance phase ]

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

Estimated Enrollment: 3300
Study Start Date: February 2016
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Topiramate
Other Name: TPM
Experimental: Experimental:Danzhen
The treatment with Danzhen is 3 tablets triple daily.
Drug: Danzhen

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645370


Contacts
Contact: Yajie Wang, MM 944759069@qq.com
Contact: Gang Zhao, MD

Locations
China, Shanxi
Xijing Hospital Not yet recruiting
Xi'an, Shanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Ecion Pharmaceutical CO..LTD
Investigators
Study Director: Gang Zhao, MD Xijing Hospital
  More Information

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02645370     History of Changes
Other Study ID Numbers: Xijing-APP-CER
First Submitted: December 30, 2015
First Posted: January 1, 2016
Last Update Posted: January 1, 2016
Last Verified: December 2015

Keywords provided by Xijing Hospital:
Migraine
Danzhen
Topiramate
Headache diary APP
preventive treatment

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents