MigrainePhase 4ENMNMNCT03175900
Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine
A Phase 4 study testing Naoan dripping pills in people with Migraine, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to investigate the effects and neural mechanism of Naoan dripping pills on migraine patients by utilizing fMRI and DTI method, as well as headache evaluation measures such as responder rate, headache duration, PRO scale, etc. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Naoan dripping pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2017to 4 Aug 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has migraine without aura or with typical aura according to criteria of the International Headache Society (IHS)
- Subject has been diagnosed with qi deficiency syndrome and/or blood stasis syndrome in TCM
- Subject has onset of migraine occurring before age 50
- Subject has a history of migraine headaches for at least 1 year
- In recent 3 months, subject has 2 to 8 headache attacks every 4 weeks
- Age ≥ 18 years and ≤ 65 years
- Right-handers
- Subject has signed informed consent
Who cannot join
- Subject takes painkillers more than 10 days a month for headache attacks
- Subject who was／is in possess of Naoan dripping pills therapy but the treatment is ineffective
- Allergic to Naoan dripping pills
- subject's taken, within 12 weeks before enrollment, migraine prevention drugs drugs such as β-blocker, calcium channel inhibitor，Anti-epileptic drugs，antidepressants or 5-HT receptor blocker
- Alcohol or drug abusers
- Subject suffers from other primary headaches as specified by IHS criteria
Show all 11Show fewer
- Subject has medical condition such as severe heart disease, stroke, kidney disease, liver disease, hepatic or renal impairment, hematologic disease
- Subject has psychological or mental disorder, Hamilton Anxiety Scale（HAMA）≥7，Hamilton Depression Scale（HAMD）≥7
- Subject has language impairment or cognitive impairment, unable to read, understand or record information in study diaries and questionnaires
- Pregnant or breast feeding subjects
- Subjects with contraindications for undergoing MRI scans (e.g. Claustrophobic, patients with heart pacemaker )
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to investigate the effects and neural mechanism of Naoan dripping pills on migraine patients by utilizing fMRI and DTI method, as well as headache evaluation measures such as responder rate, headache duration, PRO scale, etc.
Read the detailed description
Naoan dripping pills, which is a Chinese patent medicine proved effectively in treating migraine on clinic, but its neural mechanism remains unknown. This study is expected to validate the effectiveness and explore its neural mechanism by fMRI and DTI so as to provide evidence for physicians to promote the appropriate use of Naoan dripping pills treatment for migraine patients. Patients will be randomly assigned to either Naoan dripping pills group or placebo group, they will receive Naoan dripping pills/Placebo treatment for 12 weeks. Clinical evaluation will be performed at baseline, every 4 weeks during treatment and the follow-up week(16 weeks) . MRI scans are performed at baseline, and 12 weeks later. Responder rate (defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period) and fMRI and DTI imaging changes after treatment are defined as primary outcome. In addition, 10 healthy controls will also undergo MRI scanning at baseline to determine abnormal brain activity and structure in migraine patients.
- Conditions
- Migraine
- Being tested
- Naoan dripping pills, Placebo
- Keywords
- Migraine, Naoan dripping pills, Traditional Chinese Medicine, fMRI, Randomized Controlled trial
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naoan dripping pillsDrug
Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible.
Procedure: MRI scanning (fMRI and DTI）
PlaceboDrug
Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible.
Procedure: MRI scanning (fMRI and DTI)
| Study group | Role | What they receive |
|---|---|---|
| Naoan dripping pills for migraine | Experimental | Drug: Naoan dripping pills, Chinese patent medicine，pill. Patients will receive treatment with Naoan dripping pills for 12 weeks, Fenbid can be taken if headache is unbearable Procedure: MRI scanning（fMRI and DTI） Receives: Drug: Naoan dripping pills |
| Placebo | Placebo comparator | Drug: Placebo, pill. Patients will receive treatment with placebo for 12 weeks, Fenbid can be taken if headache is unbearable Procedure: MRI scanning （fMRI and DTI） Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder rate
Defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period
Measured: 12 weeks
Secondary outcomes (7)
Change in functional connectivity assessed by Resting-state fMRI
Investigate the differences in fractional anisotropy of migraine patients compared to healthy volunteers at baseline, and compare the changes of fractional anisotropy after 12 weeks' treatment in two groups
Measured: Baseline and 12 weeks
Change in fractional anisotropy (FA) assessed by DTI
Investigate the differences in fractional anisotropy of migraine patients compared to healthy volunteers at baseline, and compare the changes of fractional anisotropy after 12 weeks' treatment in two groups
Measured: Baseline and 12 weeks
Duration of migraine attacks
To compare the reduction of duration of migraine attacks after 12 weeks' treatment in two groups
Measured: 12 weeks and 16 weeks
Intensity of headache
To compare the change of the duration of migraine attacks (mild, moderate, severe) after 12 weeks' treatment in two groups
Measured: 12 weeks and 16 weeks
Patient reported outcome (PRO) scale of migraine
To compare the change of Patient reported scores after 12 weeks' treatment in two groups
Measured: 12 weeks and 16 weeks
Number of migraine days per evaluation interval
To compare the reduction of the number of migraine days per evaluation interval after 12 weeks' treatment in two groups
Measured: 12 weeks and 16 weeks
Drug consumption for symptomatic or acute treatment
To compare the change of drug consumption for symptomatic or acute treatment after 12 weeks' treatment in two groups
Measured: 12 weeks and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start17 Jun 2017
- Primary completion4 Jul 2018
- Study completion4 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Liaoyuan Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, MD, Principal investigator, Dongzhimen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175900
- Sponsor's protocol ID
- PRO-2016-84-01
- Acronym
- ENMNM
- Status last verified
- Feb 2019
- First submitted
- 30 May 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03175900
- Acronym / sponsor ID
- ENMNM / PRO-2016-84-01
- Conditions
- Migraine
- Keywords
- Migraine, Naoan dripping pills, Traditional Chinese Medicine, fMRI, Randomized Controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Zhejiang Liaoyuan Pharmaceutical Co., Ltd.
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Aug 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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.
This is a randomized, double-blind, placebo-controlled clinical trial. Its main purpose is to investigate the effects and neural mechanism of Naoan dripping pills on migraine patients by utilizing fMRI and DTI method, as well as headache evaluation measures such as responder rate, headache duration, PRO scale, etc.
Detailed description
Naoan dripping pills, which is a Chinese patent medicine proved effectively in treating migraine on clinic, but its neural mechanism remains unknown. This study is expected to validate the effectiveness and explore its neural mechanism by fMRI and DTI so as to provide evidence for physicians to promote the appropriate use of Naoan dripping pills treatment for migraine patients. Patients will be randomly assigned to either Naoan dripping pills group or placebo group, they will receive Naoan dripping pills/Placebo treatment for 12 weeks. Clinical evaluation will be performed at baseline, every 4 weeks during treatment and the follow-up week(16 weeks) . MRI scans are performed at baseline, and 12 weeks later. Responder rate (defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period) and fMRI and DTI imaging changes after treatment are defined as primary outcome. In addition, 10 healthy controls will also undergo MRI scanning at baseline to determine abnormal brain activity and structure in migraine patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naoan dripping pills for migraine | Experimental | Drug: Naoan dripping pillsDrug: Naoan dripping pills, Chinese patent medicine，pill. Patients will receive treatment with Naoan dripping pills for 12 weeks, Fenbid can be taken if headache is unbearable Procedure: MRI scanning（fMRI and DTI） |
| Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo, pill. Patients will receive treatment with placebo for 12 weeks, Fenbid can be taken if headache is unbearable Procedure: MRI scanning （fMRI and DTI） |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has migraine without aura or with typical aura according to criteria of the International Headache Society (IHS)
- Subject has been diagnosed with qi deficiency syndrome and/or blood stasis syndrome in TCM
- Subject has onset of migraine occurring before age 50
- Subject has a history of migraine headaches for at least 1 year
- In recent 3 months, subject has 2 to 8 headache attacks every 4 weeks
Key exclusion criteria (11 listed)
- Subject takes painkillers more than 10 days a month for headache attacks
- Subject who was／is in possess of Naoan dripping pills therapy but the treatment is ineffective
- Allergic to Naoan dripping pills
- subject's taken, within 12 weeks before enrollment, migraine prevention drugs drugs such as β-blocker, calcium channel inhibitor，Anti-epileptic drugs，antidepressants or 5-HT receptor blocker
- Alcohol or drug abusers
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 |
|---|---|---|
| Naoan dripping pillsPatients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible. Procedure: MRI scanning (fMRI and DTI） | Drug | Naoan dripping pills for migraine |
| PlaceboPatients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible. Procedure: MRI scanning (fMRI and DTI) | Drug | Placebo |
Primary outcome
Responder rate
Time frame: 12 weeks
Defined as the percentage of subjects in a treatment group with 50 % or greater reduction in attack frequency during treatment compared with the baseline period
7 secondary outcomes
Change in functional connectivity assessed by Resting-state fMRI
Time frame: Baseline and 12 weeks
Change in fractional anisotropy (FA) assessed by DTI
Time frame: Baseline and 12 weeks
Duration of migraine attacks
Time frame: 12 weeks and 16 weeks
Intensity of headache
Time frame: 12 weeks and 16 weeks
Patient reported outcome (PRO) scale of migraine
Time frame: 12 weeks and 16 weeks
Number of migraine days per evaluation interval
Time frame: 12 weeks and 16 weeks
Drug consumption for symptomatic or acute treatment
Time frame: 12 weeks and 16 weeks
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 19 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Ying Gao, MD principal investigator
Dongzhimen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naoan dripping pills in people with Migraine, run by Dongzhimen Hospital, Beijing at 1 site 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 8 inclusion and 11 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Responder rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2019.