NCT02255071

Brief Summary

In recent years, there is an increasing trend in the number of patients with Gastroesophageal reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

September 30, 2014

Last Update Submit

June 8, 2015

Conditions

Gastroesophageal Reflux Disease

Keywords

GERDNeiguanAcupressureP6

Outcome Measures

Primary Outcomes (1)

  • Reflux disease questionnaire(RDQ)

    RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.

    7 days

Secondary Outcomes (1)

  • World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)

    7 days

Study Arms (2)

Acupressure

EXPERIMENTAL

Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.

Device: Acupressure wristband

Sham-Acupressure

SHAM COMPARATOR

Patients will band a sham wristband over wrist but no acupressure for seven days.

Device: Sham wristband

Interventions

Acupressure wristbandDEVICE

A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.

Acupressure
Sham wristbandDEVICE

A wristband over wrist but no acupressure for seven days.

Sham-Acupressure

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female
  • Age of 20-60 years
  • Suffered from heartburn with or without acid regurgitation

You may not qualify if:

  • Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus
  • previously underwent the esophagus, stomach or duodenum surgery
  • Lactating women or pregnant women
  • patients with severe cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Wei-Ti Hsu, MD

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 2, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

TW(1)