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

Chengdu University of Traditional Chinese Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diarrhea-predominant Irritable Bowel Syndrome; Functional Diarrhea

Treatments: Other: acupuncture group3; Other: acupuncture group2; Drug: Loperamide; Other: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01350570

2011CB5200-Fd

Details and patient eligibility

About

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

Full description

Outcome measurements:

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

Enrollment: 449 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

449 participants in 4 patient groups

acupuncture group 1

Experimental group

Description:

Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.

Treatment:

Other: acupuncture

acupuncture group 2

Experimental group

Description:

Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.

Treatment:

Other: acupuncture group2

acupuncture group 3

Experimental group

Description:

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

Treatment:

Other: acupuncture group3

Loperamide

Active Comparator group

Description:

Loperamide will be used as an active comparator to the acupuncture groups.

Treatment:

Drug: Loperamide