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

Phase 2

Completed

• Conditions: Diarrhea-predominant Irritable Bowel Syndrome; Functional Diarrhea
• Interventions: Other: acupuncture; Other: acupuncture group2; Other: acupuncture group3; Drug: Loperamide

• Registration Number: NCT01350570
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

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

Detailed Description

Outcome measurements:

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

Study Timeline

• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Study Start: 2011-08
• Primary Completion: 2014-02
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture group 1	acupuncture	Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.
acupuncture group 2	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 group 3	acupuncture group3	All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
Loperamide	Loperamide	Loperamide will be used as an active comparator to the acupuncture groups.

Primary Outcome Measures

Name	Time	Method
Average weekly stool frequency	4th week after inclusion	Average weekly stool frequency, change from baseline in 4 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment score of Bristol stool scale	4th and 8th week after inclusion	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
Assessment score of SF-36 scale	4th and 8th after inclusion	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.
Number of patients with adverse events after treatment	4th week after inclusion	Number of patients with adverse events after treatment will be recorded and compared among three groups.

Trial Locations

Locations (1)

First affiliated hospital of Chengdu university of TCM; 🇨🇳 Chengdu, Sichuan, China