Effectiveness and Neural Mechanism of Naoan Dripping Pills for Migraine

NCT03175900 | Completed Phase 4 DMC

• 1 other identifier: PRO-2016-84-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in functional connectivity assessed by Resting-state fMRI

  Baseline and 12 weeks

• Change in fractional anisotropy (FA) assessed by DTI

  Baseline and 12 weeks

• Duration of migraine attacks

  12 weeks and 16 weeks

• Intensity of headache

  12 weeks and 16 weeks

• Patient reported outcome (PRO) scale of migraine

  12 weeks and 16 weeks

Study Arms (2)

Naoan dripping pills for migraine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Naoan dripping pills 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）

Naoan dripping pills for migraine

Placebo 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• Zhejiang Liaoyuan Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ying Gao, MD

  Dongzhimen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Dongzhimen Hospital

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 5, 2017
• Study Start: June 17, 2017
• Primary Completion: July 4, 2018
• Study Completion: August 4, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)