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

Study Overview
=================
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

Official Title
-----------------
Acupuncture for Functional Bowel Disease

Conditions
-----------------
Diarrhea-predominant Irritable Bowel Syndrome, Functional Diarrhea

Intervention / Treatment
-----------------
* Other: acupuncture
* Other: acupuncture group2
* Other: acupuncture group3
* Drug: Loperamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria; Age between 18 and 65 years old; Did not take any medicine for bowel symptoms and attend other clinical research; Have inform consent signed. Exclusion Criteria: Diarrhea caused by diseases such as infection, etc. Patients can't express himself clearly or with mental diseases; Tumor and other infectious diseases; With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture group 1<br>Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back. | Other: acupuncture<br>* acupuncture group1, acupoints ST25 and BL25 will be used in this trial.<br>* Other names: Acupuncture at Shumu acupoints;|
| Experimental: acupuncture group 2<br>Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb. | Other: acupuncture group2<br>* Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.<br>* Other names: Acupuncture at He acupoints;|
| Experimental: acupuncture group 3<br>All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group. | Other: acupuncture group3<br>* All acupoints used in acupuncture group1 and group2 will be used in this group.<br>* Other names: Acupuncture at Shumu and He acupoints;|
| Active Comparator: Loperamide<br>Loperamide will be used as an active comparator to the acupuncture groups. | Drug: Loperamide<br>* Loperamide will be used in this group for a dose of 2mg a time, three time a day.<br>* Other names: Luopaidingan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average weekly stool frequency | Average weekly stool frequency, change from baseline in 4 weeks | 4th week after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, loperamide, functional diarrhea, IBS