Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine

NCT ID: NCT03175900

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-17
• Study Completion Date: 2018-08-04

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Naoan dripping pills for migraine

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）

Group Type: EXPERIMENTAL

Naoan dripping pills

Intervention Type: DRUG

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）

Placebo

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）

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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)

Interventions

Naoan dripping pills

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）

Intervention Type: DRUG

Placebo

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)

Intervention Type: DRUG

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 )

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Liaoyuan Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Ying Gao

Vice president of Dongzhimen Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Dongzhimen Hospital

Locations

Dongzhimen Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PRO-2016-84-01

Identifier Type: -

Identifier Source: org_study_id