Trial record 2 of 116 for:
Open Studies | "Diarrhea"
Acupuncture for Patients With Diarrhea-predominant IBS: a Randomized Controlled Trial
This study is currently recruiting participants.
Verified May 2013 by Chengdu University of Traditional Chinese Medicine
Sponsor:
Chengdu University of Traditional Chinese Medicine
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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.
Contacts and Locations
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 Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Loperamide Antidiarrheals Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013