Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial

Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial

Official title:

Acupuncture for Functional Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350570
• Other study ID #: 2011CB5200-Fd
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 6, 2011
• Last updated: April 9, 2015
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• 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

This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.

Description:

Outcome measurements:

The frequency of bowel movement; The bristol stool scale; SF-36 evaluation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;

2. Age between 18 and 65 years old;

3. Did not take any medicine for bowel symptoms and attend other clinical research;

4. Have inform consent signed.

Exclusion Criteria:

1. Diarrhea caused by diseases such as infection, etc.

2. Patients can't express himself clearly or with mental diseases;

3. Tumor and other infectious diseases;

4. With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.

Study Design

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

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-predominant Irritable Bowel Syndrome
• Functional Diarrhea
• Irritable Bowel Syndrome

Intervention

Other:
• acupuncture
acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
• acupuncture group2
Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
• acupuncture group3
All acupoints used in acupuncture group1 and group2 will be used in this group.

Drug:
• Loperamide
Loperamide will be used in this group for a dose of 2mg a time, three time a day.

Locations

Country	Name	City	State
China	First affiliated hospital of Chengdu university of TCM	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average weekly stool frequency	Average weekly stool frequency, change from baseline in 4 weeks	4th week after inclusion	No
Secondary	Assessment score of Bristol stool scale	Bristol stool scale was designed to classify the human stool into 7 categories.; The seven types of stool are: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces. Entirely liquid	4th and 8th week after inclusion	No
Secondary	Assessment score of SF-36 scale	The Short Form (36) Health Survey (SF-36) is a survey of patient health. The SF-36 is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The chinese version of SF-36 was validated and has been widely used in acupuncture studies.	4th and 8th after inclusion	No
Secondary	Number of patients with adverse events after treatment	Number of patients with adverse events after treatment will be recorded and compared among three groups.	4th week after inclusion	Yes