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Functional DyspepsiaNCT01921504

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

A study testing Acupuncture in people with Functional Dyspepsia, run by Kyunghee University Medical Center at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is to investigate the effect of acupuncture treatment on functional dyspepsia. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Functional Dyspepsia
What is being tested?
Acupuncture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
2 sitesSouth Korea
Study dates
Aug 2013to Feb 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Bothersome postprandial fullness
  • Early satiation
  • Epigastric pain
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Jae-Woo Park, KMD, PhD contact

+82-2-440-6219

pjw2907@khu.ac.kr

Seok-Jae Ko, KMD, Doctor's course contact

+82-2-440-6245

kokokoko119@hanmail.net

South Korea2 sites, 2 recruiting

  • Kyung Hee University Oriental Medicine Hospital

    Seoul, Dongdaemun-gu, 130-872

    Jin-sung Kim, KMD, PhD, +82 2 958 8895, oridoc@khu.ac.kr

    Jin-sung Kim, KMD, PhD

    Recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul, Gangdong-gu, 130-701

    Jae-Woo Park, KMD, PhD, +82 2 440 6219, pjw2907@khu.ac.kr

    Jae-Woo Park, KMD, PhD

    Recruiting

Other trials in South Korea

About this study

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

Read the detailed 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.

Being tested
Acupuncture
Keywords
Functional Dyspepsia, Acupuncture, Genotype, Ghrelin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureDevice

    Also called Acupuncture treatment

    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
Study groups in NCT01921504
Study groupRoleWhat they receive
AcupunctureExperimentalParticipants in this group are given twice-a-week acupuncture treatment for 4 weeks.
Receives: Device: Acupuncture
No treatmentNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of responders

    The proportion of patients who answer "Yes" to more than half of adequate relief questions in the treatment period.

    Patients are expected to report their response to the acupuncture treatment by answering the following question at each visit: "After the last visit, have you had adequate relief of your stomach pain or discomfort?" Questions will be asked at each visit during treatment period (Twice a week for 4 wks, total 8 times - 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 wks). Responders are defined as patients reporting adequate relief for at least 50% of the study period (more than 4 times of "Yes" to adequate relief question out of total 8 questions). The proportion of responder will be compared statistically between experimental group and no intervention group.

    Measured: Once in treatment period (4 wks)

Secondary outcomes (7)

  1. Nepean Dyspepsia Index - Korean version (NDI-K)

    The Nepean Dyspepsia Index is a reliable and valid measure of quality of life in FD. The Nepean Dyspepsia Index originally contains 42 items designed to measure impairment of a subject's ability to engage in relevant aspects of their life because of dyspepsia. It was subsequently shortened to 25 items, yielding 5 sub-scales. NDI-K, validated in 2004 by Choi at al., made up of 2 sections which are about symptom-based questions and quality of life. In this trial, symptom-based questions, i.e. questions about period, severity and distressful degree of 15 symptoms, will be evaluated.

    Measured: After treatment (4 wks)

  2. EuroQol-5 Dimension (EQ-5D)

    EQ-5D is a standardized instrument as a measure of health outcome. EQ-5D consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    First page is made up of 5 questions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 3 levels: no problem, some problems, major problems.

    Second page consists of EQ VAS and its explanation. EQ VAS records the respondent's self-rated health on a vertical visual analogue scale where each endpoint is labelled either 'Best imaginable health state' and 'Worst imaginable health state'.

    Measured: After treatment (4 wks)

  3. Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire

    The FD-QOL scale is a 21-item Likert-type questionnaire that can easily be completed within 5 min. Short administration time and high comprehensibility supports the feasibility of measuring health-related quality of life.

    Measured: After treatment (4 wks)

  4. Beck's Depression Inventory (BDI)

    The Beck Depression Inventory (BDI), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression.

    Measured: After treatment (4 wks)

  5. The State-Trait Anxiety Inventory (STAI)

    The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety (anxiety triggered by a specific event), and trait anxiety (anxiety derived from personal characteristic). Higher scores are positively correlated with higher levels of anxiety.

    Measured: After treatment (4 wks)

  6. Ghrelin hormone measurement (1. Total ghrelin, 2. Deacylated ghrelin)

    Ghrelin is a gut-derived peptide found in the stomach. It is known to play a role in the regulation of gastric motility and appetite.

    Measured: After treatment (4 wks)

  7. Genotype analysis by Axiom® exome genotyping arrays

    Genome-wide association study (GWAS)examines genetic variants in different individuals to see if any variant is associated with a trait. In this study, the GWAS is planned to elucidate any associations between genetic difference and response to acupuncture treatment in FD patients.

    Measured: First visit (0 wk)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionDec 2013 (estimated)
  4. Study completionFeb 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01921504
Sponsor's protocol ID
KHNMC-OH-IRB 2013-006
Status last verified
Aug 2013
First submitted
7 Aug 2013
Last updated
13 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24655542

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Functional Dyspepsia, run by Kyunghee University Medical Center at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jae-Woo Park, KMD, PhD (+82-2-440-6219, pjw2907@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of responders (time frame: Once in treatment period (4 wks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01921504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.

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