Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial
NCT ID: NCT01921504
Last Updated: 2013-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
76 participants
INTERVENTIONAL
2013-08-31
2014-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acupuncture
Participants in this group are given twice-a-week acupuncture treatment for 4 weeks.
Acupuncture
Acupuncture treatment
1. Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory)
2. Needling details 2a) Number of needle insertions per subject per session: 9-19 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Spleen(SP)4, Conception Vessel(CV)12 Optional points - Gallbladder(GB)21, Small Intestine(SI)14, Pericardium(PC)6, External points of Hand and Neck(EX-HN)5, Stomach(ST)34 2c) Depth: 5 \~ 30mm 2d) Response sought: 'Deqi' 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 25 X 30 mm, sterilized stainless steel needle, Dongbang Inc., Korea
No treatment
The participants in this group are supposed to wait without any intervention for first 4 weeks. Then they receive the identical acupuncture treatments as in the treatment group for the following 4 weeks.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acupuncture
Acupuncture treatment
1. Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory)
2. Needling details 2a) Number of needle insertions per subject per session: 9-19 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Spleen(SP)4, Conception Vessel(CV)12 Optional points - Gallbladder(GB)21, Small Intestine(SI)14, Pericardium(PC)6, External points of Hand and Neck(EX-HN)5, Stomach(ST)34 2c) Depth: 5 \~ 30mm 2d) Response sought: 'Deqi' 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 25 X 30 mm, sterilized stainless steel needle, Dongbang Inc., Korea
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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:
1. Bothersome postprandial fullness
2. Early satiation
3. Epigastric pain
4. Epigastric burning
* 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
* One who has obvious signs of irritable bowel syndrome (IBS)
* One who has alarm symptoms (weight loss, black or tar stool, dysphagia)
* One who has serious structural disease (disease of heart, lung, liver or kidney) or mental illness
* One who has had surgery related with the gastrointestinal tract (Appendectomy more than 6 months ago is acceptable)
* One who is pregnant or breastfeeding
* One who is taking drugs which might affect gastrointestinal tract (Wash-out period: 2 weeks before participating in the trial)
* One who is HIV-positive
* One who has a problem of malabsorption or maldigestion
* One who has difficulties in attending the trial or receiving treatments (e.g Paralysis, serious mental illness, dementia, drug addiction, busyness, severe disorder in vision or hearing, impossibility of visit, illiterate, etc.)
* One who does not want to sign the informed consents
* One who has clotting disorders or leukopenia, pace-maker, seizure disorders or is taking anticoagulant therapy
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acupuncture and Meridian Science Research Center
OTHER
Kyunghee University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jae-Woo Park
Associate Professor, Department of Korean Internal Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jae-woo Park, Doctor's degree
Role: PRINCIPAL_INVESTIGATOR
Kyung Hee University Hospital at Gangdong, Seoul, Repulic of Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kyung Hee University Oriental Medicine Hospital
Seoul, Dongdaemun-gu, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jin-sung Kim, KMD, PhD
Role: primary
Jae-Woo Park, KMD, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Han G, Ko SJ, Park JW, Kim J, Yeo I, Lee H, Kim SY, Lee H. Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial. Trials. 2014 Mar 22;15:89. doi: 10.1186/1745-6215-15-89.
Related Links
Access external resources that provide additional context or updates about the study.
Acupuncture and Meridian Science Research Center (AMSRC)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KHNMC-OH-IRB 2013-006
Identifier Type: -
Identifier Source: org_study_id