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

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ClinicalTrials.gov Identifier: NCT04057547
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief 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 ".

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Modified Gegen Qinlian Decoction Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
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
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.

Active Comparator: Control group
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.




Primary Outcome Measures :
  1. Improved Mayo scale [ Time Frame: Change from Baseline disease activity at 4weeks ]
  2. The Clinical Global Impression of severity Scale ( CGI-S) [ Time Frame: Change from Baseline Impression of severity at 4weeks ]

Secondary Outcome Measures :
  1. Improved Baron endoscopic scale of UC activity [ Time Frame: 4 weeks ]
  2. Improved Truelove & Witts scale [ Time Frame: 4 weeks ]
  3. The Montreal classification of inflammatory bowel disease [ Time Frame: 4 weeks ]
  4. The short form 36 (SF-36) health survey questionnaire [ Time Frame: 4 weeks ]
  5. The scores of TCM(Traditional Chinese Medicine) syndrome [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057547


Contacts
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Contact: Jiaqi Zhang, MD +8615210595175 zjq405@163.com

Locations
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China, Beijing
Xiyuanhospital Recruiting
Beijing, Beijing, China, 100091
Contact: Jiaqi Zhang, MD    +8615210595175      
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences

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Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04057547     History of Changes
Other Study ID Numbers: 81830018
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases