Text Size

Acupuncture for Patients With Function Dyspepsia

This study is currently recruiting participants.
Verified March 2013 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Hunan University of Traditional Chinese Medicine
Chongqing Medical University
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01671670
First received: August 21, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Functional Dyspepsia
Postprandial Distress Syndrome
 Other: acupuncture
Other: sham acupuncture
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Acupuncture for Patients With Functional Dyspepsia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Patients' global assessments of efficacy [ Time Frame: at 16 weeks after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • validated Leeds Dyspepsia Questionnaire [ Time Frame: 4, 8, 16, 20, 24 weeks after inclusion ] [ Designated as safety issue: No ]
  • Nepean dyspepsia index [ Time Frame: 4, 8, 16, 20, 24 weeks after inclusion ] [ Designated as safety issue: No ]
  • adverse events in each group [ Time Frame: 4 weeks after inclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acupuncture group
use traditional acupuncture to treat functional dyspepsia
 Other: acupuncture
In this group, acupuncture is given according to traditional acupuncture theories.
Other Name: use hwato acupuncture needles
Sham Comparator: sham acupuncture group
use penetrating sham acupuncture to manage functional dyspepsia
 Other: sham acupuncture
Sham acupuncture points will be used in this trial, with needle penetration.
Other Name: verum acupuncture

Detailed Description:

Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671670

Contacts
Contact: Fan-rong Liang 86-13438151411 acuresearch@126.com

Locations
China, Sichuan
Chengdu University of TCM Recruiting
Chengdu, Sichuan, China, 610075
Contact: Fan-rong Liang, MD     86-13438151411     acuresearch@126.com    
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Hunan University of Traditional Chinese Medicine
Chongqing Medical University
Investigators
Study Chair: Fan-rong Liang, MD Chengdu University of TCM
  More Information

Publications:

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01671670     History of Changes
Other Study ID Numbers: 2012CB518501-3, 2012CB518501
Study First Received: August 21, 2012
Last Updated: March 26, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chengdu University of Traditional Chinese Medicine:
Functional dyspepsia
postprandial distress syndrome

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 23, 2013