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Functional Dyspepsia | Effect of Acupuncture on Patients With Functional Dyspepsia: a Multi-center, Randomized, Waitlist-controlled Trial

Functional Dyspepsia research study

What is the primary objective of this study?

The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia.

Who is eligible to participate?

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: 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 peptic ulcer or gastroesophageal reflux disease (GERD) - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Functional Dyspepsia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:AcupunctureAcupuncture treatment Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory) 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

AcupunctureParticipants in this group are given twice-a-week acupuncture treatment for 4 weeks.

No treatmentThe 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.

Study Status

Unknown status

Start Date: August 2013

Completed Date: February 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Proportion of responders

Secondary Outcome: Nepean Dyspepsia Index - Korean version (NDI-K)

Study sponsors, principal investigator, and references

Principal Investigator: Jae-woo Park, Doctor's degree

Lead Sponsor: Kyunghee University Medical Center

Collaborator: Acupuncture and Meridian Science Research Center

More information:https://clinicaltrials.gov/show/NCT01921504

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