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

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

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 ".

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Modified Gegen Qinlian Decoction

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jiaqi Zhang, MD; Phone Number: +8615210595175; Email: zjq405@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Recruiting
      • Xiyuanhospital
      • Contact: Jiaqi Zhang, MD; Phone Number: +8615210595175

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): July 1, 2019
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 10, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 81830018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No