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

This study is currently recruiting participants.
Verified September 2017 by Ying Gao, Dongzhimen Hospital, Beijing
Sponsor:
ClinicalTrials.gov Identifier:
NCT03175900
First Posted: June 5, 2017
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Liaoyuan Yulongdongya Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Ying Gao, Dongzhimen Hospital, Beijing
  Purpose
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.

Condition Intervention Phase
Migraine Drug: Naoan dripping pills Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Ying Gao, Dongzhimen Hospital, Beijing:

Primary Outcome Measures:
  • Responder rate [ Time Frame: 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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 [ Time Frame: Baseline and 12 weeks ]
    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

  • Duration of migraine attacks [ Time Frame: 12 weeks and 16 weeks ]
    To compare the reduction of duration of migraine attacks after 12 weeks' treatment in two groups

  • Intensity of headache [ Time Frame: 12 weeks and 16 weeks ]
    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 [ Time Frame: 12 weeks and 16 weeks ]
    To compare the change of Patient reported scores after 12 weeks' treatment in two groups

  • Number of migraine days per evaluation interval [ Time Frame: 12 weeks and 16 weeks ]
    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 [ Time Frame: 12 weeks and 16 weeks ]
    To compare the change of drug consumption for symptomatic or acute treatment after 12 weeks' treatment in two groups


Estimated Enrollment: 34
Actual Study Start Date: June 17, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
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 Comparator: 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)
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)


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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has migraine without aura or with typical aura according to criteria of the International Headache Society (IHS)
  • 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 )
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175900


Contacts
Contact: Ying Gao, MD 0086-010-84013209 gaoying973@126.com
Contact: Tianli Lyu, MD (+86)15116967005 ltl.1990@163.com

Locations
China, Beijing
Dongzhimen Hospital Recruiting
Beijing, Beijing, China, 100700
Contact: Ying Gao, MD    0086-010-84013209    gaoying973@126.com   
Contact: Tianli Lyu, MD    0086-15116967005    ltl.1990@163.com   
Sponsors and Collaborators
Dongzhimen Hospital, Beijing
Liaoyuan Yulongdongya Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Ying Gao, MD Dongzhimen Hospital
  More Information

Responsible Party: Ying Gao, Vice president of Dongzhimen Hospital, Dongzhimen Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03175900     History of Changes
Other Study ID Numbers: PRO-2016-84-01
First Submitted: May 30, 2017
First Posted: June 5, 2017
Last Update Posted: October 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ying Gao, Dongzhimen Hospital, Beijing:
Migraine
Naoan dripping pills
Traditional Chinese Medicine
fMRI
Randomized Controlled trial

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases