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

This study has been completed.
Sponsor:
Collaborator:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01350570
First received: May 6, 2011
Last updated: April 9, 2015
Last verified: April 2015

May 6, 2011
April 9, 2015
August 2011
February 2014   (final data collection date for primary outcome measure)
Average weekly stool frequency [ Time Frame: 4th week after inclusion ] [ Designated as safety issue: No ]
Average weekly stool frequency, change from baseline in 4 weeks
The number of months patients were classified an adequate overall relief [ Time Frame: 4th week after inclusion ] [ Designated as safety issue: No ]
The time frame-4th week after inclusion is the end of the treatment.
Complete list of historical versions of study NCT01350570 on ClinicalTrials.gov Archive Site
  • Assessment score of Bristol stool scale [ Time Frame: 4th and 8th week after inclusion ] [ Designated as safety issue: No ]

    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 [ Time Frame: 4th and 8th after inclusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4th week after inclusion ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events after treatment will be recorded and compared among three groups.
Same as current
Not Provided
Not Provided
 
Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial
Acupuncture for Functional Bowel Disease
This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.

Outcome measurements:

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diarrhea-predominant Irritable Bowel Syndrome
  • Functional Diarrhea
  • Other: acupuncture
    acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
    Other Name: Acupuncture at Shumu acupoints
  • Other: 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.
    Other Name: Acupuncture at He acupoints
  • Other: acupuncture group3
    All acupoints used in acupuncture group1 and group2 will be used in this group.
    Other Name: Acupuncture at Shumu and He acupoints
  • Drug: Loperamide
    Loperamide will be used in this group for a dose of 2mg a time, three time a day.
    Other Name: Luopaidingan
  • Experimental: acupuncture group 1
    Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.
    Intervention: Other: acupuncture
  • Experimental: acupuncture group 2
    Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
    Intervention: Other: acupuncture group2
  • Experimental: acupuncture group 3
    All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
    Intervention: Other: acupuncture group3
  • Active Comparator: Loperamide
    Loperamide will be used as an active comparator to the acupuncture groups.
    Intervention: Drug: Loperamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
449
September 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01350570
2011CB5200-Fd
Yes
Not Provided
Not Provided
Chengdu University of Traditional Chinese Medicine
Chengdu University of Traditional Chinese Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Principal Investigator: Ying Li, MD, PhD Chengdu University of TCM
Chengdu University of Traditional Chinese Medicine
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP