A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.
- Registration Number
- NCT02035111
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 947
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tianshu capsule Tianshu capsule Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks. Sugar pill Sugar pill Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Change in number of concomitant migrainous symptoms attacks 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 Proportion of subjects whose number or days of migraine attacks reduce at least 50%. -4w,0,4w,8w,12w,16w Change in seizure duration 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 Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests. 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.
Trial Locations
- Locations (20)
Langfang hospital of Traditional Chinese Medicine
🇨🇳Langfang, Hebei, China
Tangshan TCM Hospital
🇨🇳Tangshan, Hebei, China
Wuhan sixth hospital
🇨🇳Wuhan, Hubei, China
Jilin brain hospital
🇨🇳Siping, Jilin, China
Jining First Hospital
🇨🇳Jining, Shandong, China
SanMing First Hospital
🇨🇳Sanming, Fujian, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The People's Hospital,Huaibei
🇨🇳Huaibei, Anhui, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Quanzhou First Hospita
🇨🇳Quanzhou, Fujian, China
Kaifeng hospital of Traditional Chinese Medicine
🇨🇳Kaifeng, Henan, China
The two six zero hospital of Chinese people's Liberation Army
🇨🇳Shijiazhuang, Hebei, China
Daxing hospital of Traditional Chinese Medicine
🇨🇳Beijing, Beijing, China
Yiyang central hospital
🇨🇳Yiyang, Hunan, China
The Affiliated Hospital of Changchun University of Chinese medicine
🇨🇳Changchun, Jilin, China
Jinan hospital of traditional Chinese Medicine
🇨🇳Jinan, Shandong, China
The second affiliated hospital of Shandong Traditional Chinese Medicine University
🇨🇳Jinan, Shandong, China
The People's Hospital,Cangzhou
🇨🇳Cangzhou, Hebei, China
Luohe hospital of Traditional Chinese Medicine
🇨🇳Luohe, Henan, China
Xi An Hospital of Traditional Chinese Medicine
🇨🇳Xian, Shanxi, China