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

NCT ID: NCT04057547

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Modified Gegen Qinlian Decoction

Intervention Type: 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

Mesalazine sustained-release granules, orally, 0.5g/time, 4-6 times/d Bifico(Bifidobacterium triple viable capsule), orally，2 capsules/time, 2 days/time.

Group Type: ACTIVE_COMPARATOR

Modified Gegen Qinlian Decoction

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xiyuanhospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiaqi Zhang, MD

Role: CONTACT

zjq405@163.com

+8615210595175

Facility Contacts

Jiaqi Zhang, MD

Role: primary

+8615210595175

Other Identifiers

81830018

Identifier Type: -

Identifier Source: org_study_id