NCT01921504

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

August 7, 2013

Last Update Submit

August 9, 2013

Conditions

Functional Dyspepsia

Keywords

Functional DyspepsiaAcupunctureGenotypeGhrelin

Outcome Measures

Primary Outcomes (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.

    Once in treatment period (4 wks)

Secondary Outcomes (7)

  • Nepean Dyspepsia Index - Korean version (NDI-K)

    After treatment (4 wks)

  • EuroQol-5 Dimension (EQ-5D)

    After treatment (4 wks)

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

    After treatment (4 wks)

  • Beck's Depression Inventory (BDI)

    After treatment (4 wks)

  • The State-Trait Anxiety Inventory (STAI)

    After treatment (4 wks)

  • +2 more secondary outcomes

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Device: Acupuncture

No treatment

NO INTERVENTION

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.

Interventions

AcupunctureDEVICE

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

Also known as: Acupuncture treatment
Acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kyung Hee University Oriental Medicine Hospital

Seoul, Dongdaemun-gu, 130-872, South Korea

RECRUITING

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 130-701, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24655542DERIVED

Related Links

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Jae-woo Park, Doctor's degree

    Kyung Hee University Hospital at Gangdong, Seoul, Repulic of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Woo Park, KMD, PhD

CONTACT

+82-2-440-6219pjw2907@khu.ac.kr

Seok-Jae Ko, KMD, Doctor's course

CONTACT

+82-2-440-6245kokokoko119@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Korean Internal Medicine

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

August 13, 2013

Record last verified: 2013-08

Locations

KR(2)