A Phase 2/3 interventional study of acupuncture and acupuncture group2 in Diarrhea-predominant Irritable Bowel Syndrome and Functional Diarrhea, sponsored by Chengdu University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-10.
Sponsored by Chengdu University of Traditional Chinese Medicine · Phase 2/3, Interventional, and Treatment
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
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 449 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Chengdu University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.
Other: acupuncture
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
All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
Other: acupuncture group3
Loperamide will be used as an active comparator to the acupuncture groups.
Drug: Loperamide
acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
Also known as: Acupuncture at Shumu acupoints
Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
Also known as: Acupuncture at He acupoints
All acupoints used in acupuncture group1 and group2 will be used in this group.
Also known as: Acupuncture at Shumu and He acupoints
Loperamide will be used in this group for a dose of 2mg a time, three time a day.
Also known as: Luopaidingan
Average weekly stool frequency
Average weekly stool frequency, change from baseline in 4 weeks
Time frame: 4th week after inclusion
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
Time frame: 4th and 8th week after inclusion
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.
Time frame: 4th and 8th after inclusion
Number of patients with adverse events after treatment
Number of patients with adverse events after treatment will be recorded and compared among three groups.
Time frame: 4th week after inclusion
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Chengdu University of Traditional Chinese Medicine