Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine

• Status: Completed
• Trial end date: 2018-08-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dongzhimen Hospital, Beijing
• Collaborators: Liaoyuan Yulongdongya Pharmaceutical Co., Ltd.; Zhejiang Liaoyuan Pharmaceutical Co., Ltd.

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 )