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Completed

NCT Number: NCT00786214

Treatment of Functional Dyspepsia With Acupuncture

Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity.

Exclusion criteria

  • Subjects unable to give informed consent
  • Pregnant or breast-feeding females or women who get pregnant midway
  • Subjects who have received acupuncture treatment before
  • Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy
  • Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study
  • Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study
  • Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study
  • H. pylori eradication treatment within the past 12 months before study start
  • H. pylori positive patients
  • Patients with bleeding diathesis
  • Known or suspected hypersensitivity to acupuncture.

Treatment and study plan

Acupuncture

Other

Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists

Sham Acupuncture

Other

Patients will be given sham acupuncture treatment at dummy acupuncture points

Primary outcomes

  1. Resolution of symptoms

    Time frame: 4 weeks

Secondary outcomes

  1. Health-related quality of life and hospital anxiety & depression scale

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2008
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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