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

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

Detailed Description
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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.

Official Title
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To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.

Conditions
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Migraine

Intervention / Treatment
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* Drug: Tianshu capsule
* Drug: Sugar pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tianshu capsule<br>Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks. | Drug: Tianshu capsule<br> <br> |
| Placebo Comparator: Sugar pill<br>Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks. | Drug: Sugar pill<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline |  | -4w,0,4w,8w,12w,16w | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Tianshu capsule