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

Chengdu University of Traditional Chinese Medicine449 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

449

Conditions

Diarrhea-predominant Irritable Bowel Syndrome Functional Diarrhea

Interventions

acupunctureOTHER

acupuncture group1, acupoints ST25 and BL25 will be used in this trial.

acupuncture group2OTHER

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 group3OTHER

All acupoints used in acupuncture group1 and group2 will be used in this group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

First affiliated hospital of Chengdu university of TCM

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Average weekly stool frequency

Average weekly stool frequency, change from baseline in 4 weeks

Time frame: 4th week after inclusion

Secondary Outcomes

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

Time frame: 4th and 8th week after inclusion

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.

Time frame: 4th and 8th after inclusion

Number of patients with adverse events after treatment

Number of patients with adverse events after treatment will be recorded and compared among three groups.

Time frame: 4th week after inclusion

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.