NCT01671670

Brief Summary

Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia Design:

  • A single blind randomized controlled trial
  • 200 participants will be included
  • Two arms: acupuncture and sham acupuncture group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

August 21, 2012

Last Update Submit

November 25, 2014

Conditions

Functional DyspepsiaPostprandial Distress Syndrome

Keywords

Functional dyspepsiapostprandial distress syndrome

Outcome Measures

Primary Outcomes (1)

  • The proportion of participants reporting complete absence of dyspeptic symptoms

    at 16 weeks after inclusion

Secondary Outcomes (3)

  • validated Leeds Dyspepsia Questionnaire

    4, 8, 16, 20, 24 weeks after inclusion

  • Nepean dyspepsia index

    4, 8, 16, 20, 24 weeks after inclusion

  • adverse events in each group

    4 weeks after inclusion

Study Arms (2)

acupuncture group

EXPERIMENTAL

use traditional acupuncture to treat functional dyspepsia

Other: acupuncture

sham acupuncture group

SHAM COMPARATOR

use penetrating sham acupuncture to manage functional dyspepsia

Other: sham acupuncture

Interventions

acupunctureOTHER

In this group, acupuncture is given according to traditional acupuncture theories.

Also known as: use hwato acupuncture needles
acupuncture group
sham acupunctureOTHER

Sham acupuncture points will be used in this trial, with needle penetration.

Also known as: verum acupuncture
sham acupuncture group

Eligibility Criteria

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

You may qualify if:

  • Consistent with the diagnostic criteria of functional dyspepsia.
  • Age of a subject is older than 18 and is younger than 65.（including 18 and 65）
  • Include postprandial distress syndrome.
  • Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.
  • Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

  • Patients with any contraindications of Itopride.
  • Patients who are unconscious, psychotic.
  • Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
  • With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
  • Pregnant women or women in lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu University of TCM

Chengdu, Sichuan, 610075, China

Location

Related Publications (2)

  • Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.

    PMID: 22243034BACKGROUND

  • Zheng H, Xu J, Li J, Li X, Zhao L, Chang X, Liu M, Gong B, Li X, Liang F. Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial. BMJ Open. 2013 Jul 30;3(7):e003377. doi: 10.1136/bmjopen-2013-003377.

    PMID: 23901030DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Fan-rong Liang, MD

    Chengdu University of TCM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 23, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2014

Study Completion

November 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

CN(1)