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Clinical trial to evaluate the safety and efficacy of cinnamon extracts on the improvement of bowel function and microflora

Not Applicable
Completed
Conditions
Diseases of the digestive system
Registration Number
KCT0003399
Lead Sponsor
Semyung University Oriental Medicine Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
70
Inclusion Criteria

1) Subject who voluntarily agrees to participate and sign in informed consent form
2) Adults (20 years= Age)
3) Subject who has defecation difficulty by diarrhea
- According to Rome III criteria(functional diarrhea)

Exclusion Criteria

1) Subject who has condition within 4 weeks as below
- Subject who has taken probiotics, prebiotics (dietary fiber, oligosaccharide) over 1 week consistently.
- Subject who takes antibiotics over 1 week consistently.
2) Subject who has symptoms as below or takes related drugs
- irritable bowel syndrome, alcoholism, cardiovascular disease(including uncontrolled hypertension), immunological disease, psychiatric disorder
- dysfunction of liver(AST or ALT is higher than 3 times the upper limit of the normal range)
- dysfunction of kidney(creatinine is higher than 1.5 times the upper limit of the normal range)
3) Recommended Food Score > 36
4) Subject who has hypersensitivity to dietary supplement or ingredients contained in the supplement.
5) Subject who has been in clinical demonstration within 4 weeks
6) Pregnant woman or lactating women
7) Subject who judged incongruent by tester through clinical examination center.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
bowel habit
Secondary Outcome Measures
NameTimeMethod
fecal metabolites, fecal microbiota
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