Acupuncture for Patients With Function Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

Phase III Study of Acupuncture for Patients With Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671670
• Other study ID #: 2012CB518501-3
• Secondary ID: 2012CB518501
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 21, 2012
• Last updated: November 25, 2014
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis
• Postprandial Distress Syndrome

Intervention

Other:
• acupuncture
In this group, acupuncture is given according to traditional acupuncture theories.
• sham acupuncture
Sham acupuncture points will be used in this trial, with needle penetration.

Locations

Country	Name	City	State
China	Chengdu University of TCM	Chengdu	Sichuan

Sponsors (3)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Chongqing Medical University, Hunan University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants reporting complete absence of dyspeptic symptoms		at 16 weeks after inclusion	No
Secondary	validated Leeds Dyspepsia Questionnaire		4, 8, 16, 20, 24 weeks after inclusion	No
Secondary	Nepean dyspepsia index		4, 8, 16, 20, 24 weeks after inclusion	No
Secondary	adverse events in each group		4 weeks after inclusion	Yes