A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.
NCT ID: NCT02035111
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
947 participants
INTERVENTIONAL
2014-03-31
2015-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tianshu capsule
Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks.
Tianshu capsule
Sugar pill
Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks.
Sugar pill
Interventions
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Tianshu capsule
Sugar pill
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Bionovo Medicine Development Co., Ltd.
OTHER
Jiangsu Kanion Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Shengyuan Yu
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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The People's Hospital,Huaibei
Huaibei, Anhui, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Daxing hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Quanzhou First Hospita
Quanzhou, Fujian, China
SanMing First Hospital
Sanming, Fujian, China
The People's Hospital,Cangzhou
Cangzhou, Hebei, China
Langfang hospital of Traditional Chinese Medicine
Langfang, Hebei, China
The two six zero hospital of Chinese people's Liberation Army
Shijiazhuang, Hebei, China
Tangshan TCM Hospital
Tangshan, Hebei, China
Kaifeng hospital of Traditional Chinese Medicine
Kaifeng, Henan, China
Luohe hospital of Traditional Chinese Medicine
Luohe, Henan, China
Wuhan sixth hospital
Wuhan, Hubei, China
Yiyang central hospital
Yiyang, Hunan, China
The Affiliated Hospital of Changchun University of Chinese medicine
Changchun, Jilin, China
Jilin brain hospital
Siping, Jilin, China
Jinan hospital of traditional Chinese Medicine
Jinan, Shandong, China
The second affiliated hospital of Shandong Traditional Chinese Medicine University
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Jining First Hospital
Jining, Shandong, China
Xi An Hospital of Traditional Chinese Medicine
Xian, Shanxi, China
Countries
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References
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Yu S, Ran Y, Xiao W, Tang W, Zhao J, Chen W, Zhuang H, Ouyang C, Lin H, Liu D, Chen T, Huang H, Wang B, Hao Y, Yan Z, Zhao S, Wang Y, Ni J, Wang C, Ding W, Li G, Cao J, Tian S. Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial. BMC Complement Altern Med. 2019 Dec 16;19(1):370. doi: 10.1186/s12906-019-2775-2.
Other Identifiers
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Z-TSJN-JN-Ⅳ
Identifier Type: -
Identifier Source: org_study_id
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