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Treatment of Functional Dyspepsia With Acupuncture

N

National University Health System (NUHS)

Status

Completed

Conditions

Functional Dyspepsia

Treatments

Other: Sham acupuncture
Other: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT00786214
D/06/479

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

Acupuncture
Experimental group
Description:
Patients given acupuncture treatment
Treatment:
Other: Acupuncture
Sham acupuncture
Sham Comparator group
Description:
Patients given sham acupuncture treatment
Treatment:
Other: Sham acupuncture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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