Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine

Migraine Clinical Trial

— ENMNM  

Official title:

Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175900
• Other study ID #: PRO-2016-84-01
• Status: Completed
• Phase: Phase 4
• Start date: June 17, 2017
• Est. completion date: August 4, 2018

Study information

• Verified date: February 2019
• Source: Dongzhimen Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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 )

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing	Liaoyuan Yulongdongya Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	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	Baseline and 12 weeks
Secondary	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	Baseline and 12 weeks
Secondary	Duration of migraine attacks	To compare the reduction of duration of migraine attacks after 12 weeks' treatment in two groups	12 weeks and 16 weeks
Secondary	Intensity of headache	To compare the change of the duration of migraine attacks (mild, moderate, severe) after 12 weeks' treatment in two groups	12 weeks and 16 weeks
Secondary	Patient reported outcome (PRO) scale of migraine	To compare the change of Patient reported scores after 12 weeks' treatment in two groups	12 weeks and 16 weeks
Secondary	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	12 weeks and 16 weeks
Secondary	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	12 weeks and 16 weeks