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A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035111
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
Beijing Bionovo Medicine Development Co., Ltd.
Information provided by (Responsible Party):
Jiangsu Kanion Pharmaceutical Co., Ltd

Brief Summary:
The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.

Condition or disease Intervention/treatment Phase
Migraine Drug: Tianshu capsule Drug: Sugar pill Phase 4

Detailed Description:

Primary headache disorders,particularly migraine is globally prevalent. Many studies show the burdens they impose: pain, disability, reduced quality of life (QoL), marked impairment of participation in work and social activities, and heavy financial costs.

The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. To provide a safe and effective treatment of Migraine Headache.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 947 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Tianshu capsule
Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks.
Drug: Tianshu capsule
Placebo Comparator: Sugar pill
Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.
Drug: Sugar pill



Primary Outcome Measures :
  1. Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline [ Time Frame: -4w,0,4w,8w,12w,16w ]

Secondary Outcome Measures :
  1. Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline. [ Time Frame: -4w,0,4w,8w,12w,16w ]
  2. Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline. [ Time Frame: -4w,0,4w,8w,12w,16w ]
  3. Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline. [ Time Frame: -4w,0,4w,8w,12w,16w ]
  4. Proportion of subjects whose number or days of migraine attacks reduce at least 50%. [ Time Frame: -4w,0,4w,8w,12w,16w ]
  5. Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline. [ Time Frame: -4w,0,4w,8w,12w,16w ]
  6. Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests. [ Time Frame: 0, 12w ]

    Adverse event reports will be assessed at 0, 4w, 8w, 12w, 16w. clinical laboratory tests including WBC, RBC, HGB, PLT, LEU, ERY, PRO,Stool routine, ALT, AST, TBil, ALP, GGT, BUN, Cr will be assessed at 0, 12w.

    Electrocardiogram will be assessed at 0, 12w. Vital sign measurements will be assessed at -4w, 0, 4w, 8w, 12w, 16w.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must meet the Migraine diagnosis.
  • Age of onset should be before age 50 years.
  • Migraine must have been occurring for 1 year preceding entry into the trial.
  • The number of migraine attack should be no less than 6 for a period of 3 months prior to Screening stage.
  • The number of migraine days is to be 2-8 for a period of 1 month prior to screening for entry into the trial.
  • Migraine days should be less than 15 for a period of 1 month prior to screening for entry into the trial.
  • Ages 18-65.
  • Participant can understand and complete the Headache diary.
  • All participants signed the informed consent.

Exclusion Criteria:

  • Other migraine prophylactic medication is continued 3 months prior to the drug trial.
  • Participants who have taken Tianshu capsule during 1 month prior to Screening stage.
  • The number of acute treatment for migraine is more than 10 per month.
  • Participants who have taken antipsychotics or antidepressant medications (unless only for migraine prophylaxis) during the previous 3 months.
  • Participants who abuse alcohol or other drugs.
  • Participants who are resistant to all acute migraine drugs prescribed optimally.
  • hypotension or uncontrolled hypertension.
  • Severe infections.
  • Malignancy.
  • Significant medical history of such as cardiac disease, cerebrovascular disease, liver disease, nephropathy etc.
  • Known allergies or serious side effects with Tianshu capsule in the past.
  • Breastfeeding, pregnant and potentially fertile women participant.
  • History of cluster headaches, tension-type headache, vascular headache with non-migraine, drug - dependence headache.
  • Secondary headaches, including hypertension, post-traumatic brain syndrome etc.
  • Participants who have taken migraine prophylactic medication regularly during 1 month prior to Screening stage.
  • Participants who are taking part in other clinical trials.

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): NCT02035111


Locations
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Sponsors and Collaborators
Jiangsu Kanion Pharmaceutical Co., Ltd
Beijing Bionovo Medicine Development Co., Ltd.
Investigators
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Principal Investigator: Shengyuan Yu Chinese PLA General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiangsu Kanion Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02035111    
Other Study ID Numbers: Z-TSJN-JN-Ⅳ
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by Jiangsu Kanion Pharmaceutical Co., Ltd:
Migraine
Tianshu capsule
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases