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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04057547
Other study ID # 81830018
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date April 1, 2019
Est. completion date December 31, 2023

Study information

Verified date August 2019
Source Xiyuan Hospital of China Academy of Chinese Medical Sciences
Contact Jiaqi Zhang, MD
Phone +8615210595175
Email zjq405@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 ".


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Xiyuanhospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved Mayo scale Change from Baseline disease activity at 4weeks
Primary The Clinical Global Impression of severity Scale ( CGI-S) Change from Baseline Impression of severity at 4weeks
Secondary Improved Baron endoscopic scale of UC activity 4 weeks
Secondary Improved Truelove & Witts scale 4 weeks
Secondary The Montreal classification of inflammatory bowel disease 4 weeks
Secondary The short form 36 (SF-36) health survey questionnaire 4 weeks
Secondary The scores of TCM(Traditional Chinese Medicine) syndrome 4 weeks
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