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Ulcerative colitis(UC) seriously affect the quality of life in patients. Clinically, it is effective to apply therapeutic method of clearing heat and promoting diuresis to the common syndrome of dampness-heat. Dysbiosis of intestinal microbiota is closely related to the immune imbalance and intestinal mucosal barrier injury. C1orf106/CYTH-1/ARF6 signal pathway, which derive from intestinal micro environment changes,is the mainly cause of intestinal mucosal barrier injury, and this is may be the common pathogenesis of dampness-heat syndrome in UC . Based on the clinic, the project is to study the effect and mechanism of Chinese compound formula of clearing heat and promoting dieresis in modulating intestinal microbiota dysbiosis, repairing intestinal mucosal barrier and reconstructing intestinal microenvironment. With the combination of metagenomics and metabonomics, the study compare the differences of co-metabolites of intestinal microbiota and host within the healthy people, UC patients with dampness-heat syndrome, to explore the relevance between intestinal flora and host co-metabolites. Furthermore, the experimental study is to clarify the drug targets via C1orf106/ CYTH-1/ARF6 signal pathway.Through the study of association between dampness-heat syndrome in UC and intestinal microbiota, it is of important academic significance to reveal the Chinese theory intension of "homotherapy for heteropathy ".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Mesalazine sustained-release granules, orally, 0.5g/time, 4-6 times/d Modified Gegen Qinlian Decoction, Oral, 7.2g per bag, 2 times / day, 30 minutes before breakfast and dinner |
|
| Control group | Active Comparator | Mesalazine sustained-release granules, orally, 0.5g/time, 4-6 times/d Bifico(Bifidobacterium triple viable capsule), orally,2 capsules/time, 2 days/time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Gegen Qinlian Decoction | Drug | Modified Gegen Qinlian Decoction contains Pueraria lobata 24g, Scutellaria baicalensis 9g, Coptis chinensis 9g, artillery ginger 9g, talc 9g, roasted licorice 6g, and granules are prepared according to 10:1 production process. |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Mayo scale | Change from Baseline disease activity at 4weeks | |
| The Clinical Global Impression of severity Scale ( CGI-S) | Change from Baseline Impression of severity at 4weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Baron endoscopic scale of UC activity | 4 weeks | |
| Improved Truelove & Witts scale | 4 weeks | |
| The Montreal classification of inflammatory bowel disease |
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Inclusion Criteria:
(1) It meets the diagnostic criteria of UC (left semi-colon type, active period, mild) and meets the diagnostic criteria for damp-heat syndrome.
(2) Age between 18 and 70 years old. (3) Not taking antibiotics, steroids and other hormones, Chinese herbal preparations in the past week (including) Probiotics such as oral and intravenous), microecological preparations or yogurt.
(4) The subject informed and voluntarily signed the informed consent form. ; (5) Have a certain reading ability
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaqi Zhang, MD | Contact | +8615210595175 | zjq405@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiyuanhospital | Recruiting | Beijing | Beijing Municipality | 100091 | China |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 4 weeks |
| The short form 36 (SF-36) health survey questionnaire | 4 weeks |
| The scores of TCM(Traditional Chinese Medicine) syndrome | 4 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |