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

Primary Purpose

Migraine

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Naoan dripping pills

Placebo

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Naoan dripping pills, Traditional Chinese Medicine, fMRI, Randomized Controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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 )

Sites / Locations

Dongzhimen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naoan dripping pills for migraine

Placebo

Arm 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）

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）

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Change in fractional anisotropy (FA) assessed by DTI

Duration of migraine attacks

To compare the reduction of duration of migraine attacks after 12 weeks' treatment in two groups

Intensity of headache

To compare the change of the duration of migraine attacks (mild, moderate, severe) after 12 weeks' treatment in two groups

Patient reported outcome (PRO) scale of migraine

To compare the change of Patient reported scores after 12 weeks' treatment in two groups

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

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

Full Information

NCT ID

NCT03175900

First Posted

May 30, 2017

Last Updated

February 17, 2019

Sponsor

Dongzhimen Hospital, Beijing

Collaborators

Zhejiang Liaoyuan Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03175900

Brief Title

Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine

Acronym

ENMNM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 17, 2017 (Actual)

Primary Completion Date

July 4, 2018 (Actual)

Study Completion Date

August 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dongzhimen Hospital, Beijing

Collaborators

Zhejiang Liaoyuan Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

Keywords

Migraine, Naoan dripping pills, Traditional Chinese Medicine, fMRI, Randomized Controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naoan dripping pills for migraine

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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）

Intervention Type

Drug

Intervention Name(s)

Naoan dripping pills

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

Responder rate

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in functional connectivity assessed by Resting-state fMRI

Description

Time Frame

Baseline and 12 weeks

Title

Change in fractional anisotropy (FA) assessed by DTI

Description

Time Frame

Baseline and 12 weeks

Title

Duration of migraine attacks

Description

To compare the reduction of duration of migraine attacks after 12 weeks' treatment in two groups

Time Frame

12 weeks and 16 weeks

Title

Intensity of headache

Description

To compare the change of the duration of migraine attacks (mild, moderate, severe) after 12 weeks' treatment in two groups

Time Frame

12 weeks and 16 weeks

Title

Patient reported outcome (PRO) scale of migraine

Description

To compare the change of Patient reported scores after 12 weeks' treatment in two groups

Time Frame

12 weeks and 16 weeks

Title

Number of migraine days per evaluation interval

Description

To compare the reduction of the number of migraine days per evaluation interval after 12 weeks' treatment in two groups

Time Frame

12 weeks and 16 weeks

Title

Drug consumption for symptomatic or acute treatment

Description

To compare the change of drug consumption for symptomatic or acute treatment after 12 weeks' treatment in two groups

Time Frame

12 weeks and 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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 )

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying Gao, MD

Organizational Affiliation

Dongzhimen Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dongzhimen Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100700

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine

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