Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599677
• Other study ID #: 2006CB5045012
• Secondary ID: 2006CB5045012
• Status: Completed
• Phase: N/A
• First received: January 4, 2008
• Last updated: November 8, 2011
• Start date: November 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2011
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Description:

The purpose of the study is to testify whether acupuncture is effective for functional dyspepsia, through treating functional dyspepsia patient for a month, using different acupoints according to literatures of treating migraine with acupuncture, and using Itopride as controlled group, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Consistent with the diagnostic criteria of functional dyspepsia.

2. Age of a subject is older than 18 and is younger than 65.(including 18 and 65)

3. Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.

4. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Patients with any contraindications of Itopride.

2. Patients who are unconscious, psychotic.

3. Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.

4. With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.

5. 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

Intervention

Other:
• acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

Drug:
• Itopride
Each pill weighs 50mg, once a pill, three times a day. The pills are taken half an hour before meals, and be taken 4 weeks continuously.

Locations

Country	Name	City	State
China	Chengdu University of TCM	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nepean Dyspepsia Index		4 weeks	No
Secondary	Symptoms Index of Dyspepsia		4 weeks	Yes