Clinical trial NCT02035111: A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.
Official title: To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Tianshu capsule
Lead sponsor: Jiangsu Kanion Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Bionovo Medicine Development Co., Ltd.
First posted: 2014-01-14
Enrollment: 947
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline
timeFrame: -4w,0,4w,8w,12w,16w
Secondary outcomes:
measure: Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.
timeFrame: -4w,0,4w,8w,12w,16w
measure: Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.
timeFrame: -4w,0,4w,8w,12w,16w
measure: Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.
timeFrame: -4w,0,4w,8w,12w,16w
measure: Proportion of subjects whose number or days of migraine attacks reduce at least 50%.
timeFrame: -4w,0,4w,8w,12w,16w
measure: Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.
timeFrame: -4w,0,4w,8w,12w,16w
measure: Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, and clinical laboratory tests.
timeFrame: 0, 12w
Other outcomes:
Locations:
city: Huaibei
country: China
facility: The People's Hospital,Huaibei
state: Anhui
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Daxing hospital of Traditional Chinese Medicine
state: Beijing
city: Quanzhou
country: China
facility: Quanzhou First Hospita
state: Fujian
city: Sanming
country: China
facility: SanMing First Hospital
state: Fujian
city: Cangzhou
country: China
facility: The People's Hospital,Cangzhou
state: Hebei
city: Langfang
country: China
facility: Langfang hospital of Traditional Chinese Medicine
state: Hebei
city: Shijiazhuang
country: China
facility: The two six zero hospital of Chinese people's Liberation Army
state: Hebei
city: Tangshan
country: China
facility: Tangshan TCM Hospital
state: Hebei
city: Kaifeng
country: China
facility: Kaifeng hospital of Traditional Chinese Medicine
state: Henan
city: Luohe
country: China
facility: Luohe hospital of Traditional Chinese Medicine
state: Henan
city: Wuhan
country: China
facility: Wuhan sixth hospital
state: Hubei
city: Yiyang
country: China
facility: Yiyang central hospital
state: Hunan
city: Changchun
country: China
facility: The Affiliated Hospital of Changchun University of Chinese medicine
state: Jilin
city: Siping
country: China
facility: Jilin brain hospital
state: Jilin
city: Jinan
country: China
facility: Jinan hospital of traditional Chinese Medicine
state: Shandong
city: Jinan
country: China
facility: The second affiliated hospital of Shandong Traditional Chinese Medicine University
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Jining
country: China
facility: Jining First Hospital
state: Shandong
city: Xian
country: China
facility: Xi An Hospital of Traditional Chinese Medicine
state: Shanxi
Study officials:
affiliation: Chinese PLA General Hospital
name: Shengyuan Yu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.