Diarrhea-predominant Irritable Bowel Syndrome, Functional Diarrhea
Conditions
Keywords
acupuncture, loperamide, functional diarrhea, IBS
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
Interventions
OTHERacupuncture
acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
OTHERacupuncture 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.
OTHERacupuncture group3
All acupoints used in acupuncture group1 and group2 will be used in this group.
DRUGLoperamide
Loperamide will be used in this group for a dose of 2mg a time, three time a day.
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average weekly stool frequency | 4th week after inclusion | Average weekly stool frequency, change from baseline in 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed