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The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia.
Full description
Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural lesion. FD is claimed to affect 25% of the population in South Korea. Although conventional approaches based on current evidence such as proton pump inhibitor and prokinetic agents have been used, many FD patients turn to traditional Korean Medicine treatment largely due to the lack of satisfactory effect of these treatments.
Acupuncture treatment, one of the most sought therapeutic modalities in traditional Korean Medicine, has been commonly used for gastrointestinal disorders in Korea. However, the effect of acupuncture on FD has not been rigorously evaluated. In the present study, we will investigate whether 8 sessions of acupuncture treatment over 4 weeks, in comparison with no acupuncture treatment, i.e. waitlist-control, improve symptoms of FD. Outcome measures include proportion of responder, Korean version of Nepean Dyspepsia Index, EuroQol-5 Dimension, Functional Dyspepsia-Related Quality of Life, Beck's Depression Inventory, State-Trait Anxiety Inventory and ghrelin hormone. Genome-wide association study (GWAS) will be also conducted to elucidate any possible difference in genotype between responders and non-responders to acupuncture treatment.
Enrollment
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Inclusion criteria
Age of 18 ~ 75, with a elementary-school diploma or higher, should be able to read and write Korean
One who meet Rome III FD criteria* and has been suffering from FD for the last 3 months with symptom onset at least 6 months prior to diagnosis
One or more of the following:
One who checks more than 4 points on visual analogue scale (VAS) for dyspeptic symptoms
One who has normal esophagogastroduodenoscopy results within a year and been diagnosed with FD by a specialist consultation
One who receives no other treatments during the study
One who voluntarily agrees with study protocol and signs an written informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
76 participants in 2 patient groups
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Central trial contact
Seok-Jae Ko, KMD, Doctor's course; Jae-Woo Park, KMD, PhD
Data sourced from clinicaltrials.gov
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