Treatment of Functional Dyspepsia With Acupuncture

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786214
• Other study ID #: D/06/479
• Status: Completed
• Phase: N/A
• First received: November 4, 2008
• Last updated: June 20, 2013
• Start date: February 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2013
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Other:
• Acupuncture
Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists
• Sham acupuncture
Patients will be given sham acupuncture treatment at dummy acupuncture points

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of symptoms		4 weeks	No
Secondary	Health-related quality of life and hospital anxiety & depression scale		4 weeks	No