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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04057547
• Date of registration: 10/08/2019
• Prospective Registration: No
• Primary sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Public title: Efficacy and Safety of Modified Gegen Qinlian Decoction for Ulcerative Colitis With Damp-heat Syndrome
• Scientific 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
• Date of first enrolment: April 1, 2019
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04057547
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

China

Contacts

• Name: Jiaqi Zhang, MD

• Name: Jiaqi Zhang, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Modified Gegen Qinlian Decoction

Primary Outcome(s)

Improved Mayo scale [Time Frame: Change from Baseline disease activity at 4weeks]

The Clinical Global Impression of severity Scale ( CGI-S) [Time Frame: Change from Baseline Impression of severity at 4weeks]

Secondary Outcome(s)

The Montreal classification of inflammatory bowel disease [Time Frame: 4 weeks]

The short form 36 (SF-36) health survey questionnaire [Time Frame: 4 weeks]

Improved Baron endoscopic scale of UC activity [Time Frame: 4 weeks]

Improved Truelove & Witts scale [Time Frame: 4 weeks]

The scores of TCM(Traditional Chinese Medicine) syndrome [Time Frame: 4 weeks]

Secondary ID(s)

81830018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors