Clinical trial NCT03175900: Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine
Official title: Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Migraine
Naoan dripping pills
Traditional Chinese Medicine
fMRI
Randomized Controlled trial
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Zhejiang Liaoyuan Pharmaceutical Co., Ltd.
First posted: 2017-06-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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 )

Primary outcomes:
measure: Responder rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in functional connectivity assessed by Resting-state fMRI
timeFrame: Baseline and 12 weeks
measure: Change in fractional anisotropy (FA) assessed by DTI
timeFrame: Baseline and 12 weeks
measure: Duration of migraine attacks
timeFrame: 12 weeks and 16 weeks
measure: Intensity of headache
timeFrame: 12 weeks and 16 weeks
measure: Patient reported outcome (PRO) scale of migraine
timeFrame: 12 weeks and 16 weeks
measure: Number of migraine days per evaluation interval
timeFrame: 12 weeks and 16 weeks
measure: Drug consumption for symptomatic or acute treatment
timeFrame: 12 weeks and 16 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital
name: Ying Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: