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Completed

NCT Number: NCT01350570

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

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

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Key information

Conditions

Diarrhea-predominant Irritable Bowel Syndrome Functional Diarrhea

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

First affiliated hospital of Chengdu university of TCM

Chengdu, Sichuan, 610075, China

About this study

Outcome measurements:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Other

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

Other names: Acupuncture at Shumu acupoints

acupuncture group2

Other

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 names: Acupuncture at He acupoints

acupuncture group3

Other

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

Other names: Acupuncture at Shumu and He acupoints

Loperamide

Drug

Loperamide will be used in this group for a dose of 2mg a time, three time a day.

Other names: Luopaidingan

Primary outcomes

  1. Average weekly stool frequency

    Time frame: 4th week after inclusion

    Average weekly stool frequency, change from baseline in 4 weeks

Secondary outcomes

  1. Assessment score of Bristol stool scale

    Time frame: 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

  2. Assessment score of SF-36 scale

    Time frame: 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.

  3. Number of patients with adverse events after treatment

    Time frame: 4th week after inclusion

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

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Collaborators

  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Registry information

Official study title

Acupuncture for Functional Bowel Disease

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 10, 2011
Registry last updated
Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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