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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Chengdu University of Traditional Chinese Medicine
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: May 10, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Diarrhea-predominant Irritable Bowel Syndrome
Functional Diarrhea
Other: acupuncture
Other: acupuncture group2
Other: acupuncture group3
Drug: Loperamide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Functional Bowel Disease

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Average daily stool frequency [ Time Frame: 4th week after inclusion ] [ Designated as safety issue: No ]
    Average daily stool frequency, change from baseline in 4 weeks


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 472
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: acupuncture
acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
Other Name: Acupuncture at Shumu acupoints
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.
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 Hemu acupoints
Experimental: acupuncture group 3
All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
Other: acupuncture group3
All acupoints used in acupuncture group1 and group2 will be used in this group.
Other Name: Acupuncture at Shumu and Hemu acupoints
Active Comparator: Loperamide
Loperamide will be used as an active comparator to the acupuncture groups.
Drug: Loperamide
Loperamide will be used in this group for a dose of 2mg a time, three time a day.
Other Name: Luopaidingan

Detailed Description:

Outcome measurements:

The number of months patients were classified as adequate overall relief responder during the double-blind treatment period; The bristol stool scale; SF-36 evaluation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350570

Contacts
Contact: Xiang-hong Jing, MD 010-64014411-2750

Locations
China, Sichuan
First affiliated hospital of Chengdu university of TCM Recruiting
Chengdu, Sichuan, China, 610075
Contact: Min Chen, MD    028-668765347    damiecm@yahoo.com.cn   
Sub-Investigator: Min Chen, MD         
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Ying Li, MD, PhD Chengdu University of TCM
  More Information

No publications provided

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01350570     History of Changes
Other Study ID Numbers: 2011CB5200-Fd
Study First Received: May 6, 2011
Last Updated: May 10, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chengdu University of Traditional Chinese Medicine:
acupuncture
loperamide
functional diarrhea
IBS

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Antidiarrheals
Loperamide
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014