An Early Phase 1 interventional study of Modified Gegen Qinlian Decoction in Ulcerative Colitis, sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences · Early Phase 1, Interventional, and Treatment
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 ".
1,530 studies on the registry are indexed under Colitis, Ulcerative; 407 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 1,069 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Xiyuan Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 43 studies on the registry; 6 are open to participants now.
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(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:
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
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
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.
Improved Mayo scale
Time frame: Change from Baseline disease activity at 4weeks
The Clinical Global Impression of severity Scale ( CGI-S)
Time frame: Change from Baseline Impression of severity at 4weeks
Improved Baron endoscopic scale of UC activity
Time frame: 4 weeks
Improved Truelove ＆ Witts scale
Time frame: 4 weeks
The Montreal classification of inflammatory bowel disease
Time frame: 4 weeks
The short form 36 (SF-36) health survey questionnaire
Time frame: 4 weeks
The scores of TCM(Traditional Chinese Medicine) syndrome
Time frame: 4 weeks
Ran from Apr 2019 to primary completion in Jul 2019, 3 months.
Of 66 phase 1 interventional studies under Colitis, Ulcerative, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Xiyuan Hospital of China Academy of Chinese Medical Sciences