MigrainePhase 4NCT02035111
A Randomized, Placebo-Controlled, Double-blind Study of Tianshu Capsule in the Treatment of Migraine.
A Phase 4 study testing Tianshu capsule and Sugar pill in people with Migraine, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 20 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Tianshu capsule and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 947 participants
- Where
- 20 sitesChina
- Study dates
- Mar 2014to Nov 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Ages 18-65.
- Participant can understand and complete the Headache diary.
- All participants signed the informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Daxing hospital of Traditional Chinese Medicine
Beijing, Beijing Municipality, 102600
The People's Hospital,Cangzhou
Cangzhou, Hebei, 061000
The Affiliated Hospital of Changchun University of Chinese medicine
Changchun, Jilin, 130117
The People's Hospital,Huaibei
Huaibei, Anhui, 235000
Jinan hospital of traditional Chinese Medicine
Jinan, Shandong, 250000
The second affiliated hospital of Shandong Traditional Chinese Medicine University
Jinan, Shandong, 250000
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000
Jining First Hospital
Jining, Shandong, 272000
Kaifeng hospital of Traditional Chinese Medicine
Kaifeng, Henan, 475000
Langfang hospital of Traditional Chinese Medicine
Langfang, Hebei, 065000
Luohe hospital of Traditional Chinese Medicine
Luohe, Henan, 462000
Quanzhou First Hospita
Quanzhou, Fujian, 362002
SanMing First Hospital
Sanming, Fujian, 365000
The two six zero hospital of Chinese people's Liberation Army
Shijiazhuang, Hebei, 050000
Jilin brain hospital
Siping, Jilin, 136000
Tangshan TCM Hospital
Tangshan, Hebei, 063000
Wuhan sixth hospital
Wuhan, Hubei, 430000
Xi An Hospital of Traditional Chinese Medicine
Xian, Shanxi, 710021
Yiyang central hospital
Yiyang, Hunan, 413000
About this study
Official title: To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.
The purpose of this study is to evaluate the safety and the efficacy of Tianshu capsule treating Migraine Headache.
Read the 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.
- Conditions
- Migraine
- Being tested
- Tianshu capsule, Sugar pill
- Keywords
- Migraine, Tianshu capsule
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tianshu capsuleDrug
Sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Tianshu capsule | Experimental | Four Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks. Receives: Drug: Tianshu capsule |
| Sugar pill | Placebo comparator | Four sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks. Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline
Measured: -4w,0,4w,8w,12w,16w
Secondary outcomes (6)
Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.
Measured: -4w,0,4w,8w,12w,16w
Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.
Measured: -4w,0,4w,8w,12w,16w
Change in the days using acute therapy of Migraine Per 4 weeks at Week 16 from baseline.
Measured: -4w,0,4w,8w,12w,16w
Proportion of subjects whose number or days of migraine attacks reduce at least 50%.
Measured: -4w,0,4w,8w,12w,16w
Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.
Measured: -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.
Measured: 0, 12w
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Shengyuan Yu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035111
- Sponsor's protocol ID
- Z-TSJN-JN-Ⅳ
- Status last verified
- Apr 2016
- First submitted
- 10 Jan 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31842860
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and the Efficacy of Tianshu Capsule Treating Migraine in a Randomized, Placebo-Controlled, Double-blind, Multicenter Study.
- ClinicalTrials.gov ID
- NCT02035111
- Acronym / sponsor ID
- Z-TSJN-JN-Ⅳ
- Conditions
- Migraine
- Keywords
- Migraine, Tianshu capsule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- Jiangsu Kanion Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tianshu capsule | Experimental | Drug: Tianshu capsuleFour Tianshu capsules (0.34 g per capsule) by oral three times a day for 12 weeks. |
| Sugar pill | Placebo comparator | Drug: Sugar pillFour sugar pills (0.34 g per capsule) by oral three times a day for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tianshu capsule | Drug | Tianshu capsule |
| Sugar pill | Drug | Sugar pill |
Primary outcome
Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline
Time frame: -4w,0,4w,8w,12w,16w
6 secondary outcomes
Change in seizure duration of Migraine Per 4 weeks at Week 16 from baseline.
Time frame: -4w,0,4w,8w,12w,16w
Change in degree of pain of Migraine Per 4 weeks at Week 16 from baseline.
Time frame: -4w,0,4w,8w,12w,16w
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
Proportion of subjects whose number or days of migraine attacks reduce at least 50%.
Time frame: -4w,0,4w,8w,12w,16w
Change in number of concomitant migrainous symptoms attacks Per 4 weeks at Week 16 from baseline.
Time frame: -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.
Time frame: 0, 12w
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Derived from this study: PubMed 31842860Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shengyuan Yu principal investigator
Chinese PLA General Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tianshu capsule and Sugar pill in people with Migraine, run by Jiangsu Kanion Pharmaceutical Co., Ltd at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the frequency of attack of Migraine Per 4 weeks at Week 16 from baseline (time frame: -4w,0,4w,8w,12w,16w). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02035111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.