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To explore the molecular mechanism of chronic urticaria with syndrome of dampness and heat in the intestines and stomach from the perspective of gastrointestinal microecological imbalance

Early Phase 1
Recruiting
Conditions
chronic urticaria
Registration Number
ITMCTR2022000023
Lead Sponsor
Guang'anmen Hospital, China Academy of Chinese Medicine Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion criteria for patients with chronic urticaria: 1) Age 18-50; 2) Meet the western diagnostic criteria of chronic urticaria; 3) Meet the diagnostic criteria of TCM for chronic urticaria; 4) TCM syndrome differentiation conforms to chronic urticaria gastrointestinal dampness and heat syndrome or not syndrome of dampness and heat in the intestines and stomach (wind-heat syndrome, wind-cold syndrome, toxic heat and excessive heat syndrome or qi and blood deficiency syndrome); 5) Sign informed consent.

Exclusion Criteria

Exclusion criteria for patients with chronic urticaria: 1) with acute urticaria, drug sex urticaria, induced urticaria (cold sex urticaria, hot sex urticaria, solar sex urticaria, delay pressure sex urticaria, anti-vibration effect sex urticaria, cholinergic urticaria, sex urticaria, etc.), urticaria, vasculitis and other associated with urticaria appearance of the skin disease; 2) Had received hormone, immunosuppressant or biological agent treatment in the last 3 months, or received relevant Traditional Chinese medicine treatment one week before enrollment; 3) Women who are pregnant, trying to become pregnant or breastfeeding; 4) With a history of severe respiratory, digestive, circulatory, urinary, hematological, endocrine or nervous system diseases. 5) There were the following factors affecting fecal collection: (1) gastrointestinal surgery (e.g., cholecystectomy and appendectomy) within 5 years, or other operations within 6 months; (2) a history of autoimmune disease, such as inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis of unknown etiology; (3) Previous history of irritable bowel syndrome (IBS), gastric cancer and pregastric cancer; (4) Used antibiotics within 3 months; (5) drugs containing bismuth basic salicylate and other similar bismuth basic salicylate have been used in the past 1 week; (6) Have eaten probiotic-containing food or drugs, such as yogurt and cheese, in the past 2 weeks; (7) Have bad habits such as alcoholism, men drink 5 times a week or more, women drink 4 times a week or more, the average amount of alcohol per time is more than 2 liang liquor or 5 bottles of beer. 6) Patients who refuse to sign informed consent.

Study & Design

Study Type
Observational study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
rticaria activity score 7;
Secondary Outcome Measures
NameTimeMethod
rticaria control Scale;Serum targeted metabolomics assay and cytokine assay;Time for hives subsidence;Urticaria activity score;Gastrointestinal symptom Rating Scale;Evaluation scale of TCM symptoms of gastrointestinal diseases;16SrRNA sequencing;Frequency of weekly urticaria;Dermatology Life Quality Index;
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