Efficacy and Safety of Modified Gegen Qinlian Decoction for Ulcerative Colitis With Damp-heat Syndrome

Study Overview
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Brief Summary
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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 .

Official Title
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The Correlation Within Dampness-heat Syndrome of Ulcerative Colitis(UC) and Intestinal Microbiota Via C1orf106/Cytohesin-1（CYTH-1） /Adenosine Diphosphate-ribosylation Factor 6（ARF6） Signal Pathway and the Intervention Mechanism of Classic Chinese Compound Formula With Clearing Heat and Promoting Dieresis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Modified Gegen Qinlian Decoction


Participation Criteria
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Eligibility Criteria
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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: (1) Patients with severe organ, liver, kidney and other major organ diseases, hematopoietic system, nervous system or mental illness; (2) combined with other digestive systemic lesions (such as peptic ulcer), or systemic diseases affecting digestive tract motility (eg hyperthyroidism, diabetes); (3) Those who are or need to continue to use drugs that may affect gastrointestinal function (antidiarrheals, antidepressants, anxiolytics, intestinal flora regulators, antibiotics, etc.); (4) Those with a history of allergic reactions to related drugs and a history of severe food allergies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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 | Drug: Modified Gegen Qinlian Decoction<br>* 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.<br>|
| Active Comparator: Control group<br>Mesalazine sustained-release granules, orally, 0.5g/time, 4-6 times/d Bifico(Bifidobacterium triple viable capsule), orally，2 capsules/time, 2 days/time. | Drug: Modified Gegen Qinlian Decoction<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 4 weeks | 
| The short form 36 (SF-36) health survey questionnaire |  | 4 weeks | 
| The scores of TCM(Traditional Chinese Medicine) syndrome |  | 4 weeks |