Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine (ENMNM)

Dongzhimen Hospital, Beijing

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Naoan dripping pills

Study type: Interventional

Funder types: Other

Identifiers

NCT03175900

PRO-2016-84-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

Naoan dripping pills for migraine

Experimental group

Description:

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）

Treatment:

Drug: Naoan dripping pills

Placebo

Placebo Comparator group

Description:

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）

Treatment:

Drug: Placebo