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

Primary Purpose

Diarrhea-predominant Irritable Bowel Syndrome, Functional Diarrhea

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
acupuncture
acupuncture group2
acupuncture group3
Loperamide
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea-predominant Irritable Bowel Syndrome focused on measuring acupuncture, loperamide, functional diarrhea, IBS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First affiliated hospital of Chengdu university of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

acupuncture group 1

acupuncture group 2

acupuncture group 3

Loperamide

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Average weekly stool frequency
Average weekly stool frequency, change from baseline in 4 weeks

Secondary Outcome Measures

Assessment score of Bristol stool scale
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
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
Number of patients with adverse events after treatment will be recorded and compared among three groups.

Full Information

First Posted
May 6, 2011
Last Updated
April 9, 2015
Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01350570
Brief Title
Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial
Official Title
Acupuncture for Functional Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea-predominant Irritable Bowel Syndrome, Functional Diarrhea
Keywords
acupuncture, loperamide, functional diarrhea, IBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture group 1
Arm Type
Experimental
Arm Description
Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.
Arm Title
acupuncture group 2
Arm Type
Experimental
Arm 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.
Arm Title
acupuncture group 3
Arm Type
Experimental
Arm Description
All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
Arm Title
Loperamide
Arm Type
Active Comparator
Arm Description
Loperamide will be used as an active comparator to the acupuncture groups.
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Acupuncture at Shumu acupoints
Intervention Description
acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
Intervention Type
Other
Intervention Name(s)
acupuncture group2
Other Intervention Name(s)
Acupuncture at He acupoints
Intervention 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.
Intervention Type
Other
Intervention Name(s)
acupuncture group3
Other Intervention Name(s)
Acupuncture at Shumu and He acupoints
Intervention Description
All acupoints used in acupuncture group1 and group2 will be used in this group.
Intervention Type
Drug
Intervention Name(s)
Loperamide
Other Intervention Name(s)
Luopaidingan
Intervention Description
Loperamide will be used in this group for a dose of 2mg a time, three time a day.
Primary Outcome Measure Information:
Title
Average weekly stool frequency
Description
Average weekly stool frequency, change from baseline in 4 weeks
Time Frame
4th week after inclusion
Secondary Outcome Measure Information:
Title
Assessment score of Bristol stool scale
Description
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
Time Frame
4th and 8th week after inclusion
Title
Assessment score of SF-36 scale
Description
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.
Time Frame
4th and 8th after inclusion
Title
Number of patients with adverse events after treatment
Description
Number of patients with adverse events after treatment will be recorded and compared among three groups.
Time Frame
4th week after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Li, MD, PhD
Organizational Affiliation
Chengdu University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
First affiliated hospital of Chengdu university of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

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

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