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

NCT04057547 | Unknown Early Phase 1 DMC

• 1 other identifier: 81830018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 ".

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Modified Gegen Qinlian Decoction DRUG

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.

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

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

Study Sites (1)

Xiyuanhospital

Beijing, Beijing Municipality, 100091, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Jiaqi Zhang, MD

CONTACT

+8615210595175; zjq405@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2019
• First Posted: August 15, 2019
• Study Start: April 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: December 31, 2023
• Last Updated: October 15, 2019

Record last verified: 2019-08

Locations

CN (1)