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Clinical Trials for Chronic Urticaria

Phase 1
Recruiting
Conditions
chronic urticaria
Registration Number
ITMCTR2100004975
Lead Sponsor
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Patients aged 20 to 48 years;
2. patients conforming to the diagnostic criteria of refractory chronic urticaria;
3. patients conforming to the diagnostic criteria of TCM wind-heat syndrome;
4. patients having used at least 2 times the conventional dose of antihistamines or at least 2 combined antihistamines with conventional dose for more than 2 weeks;
5. The duration of patients'hives is more than 2 hours;
6. patients able to give stool samples;
7. patients able to sign the informed consent form.

Exclusion Criteria

1. Patients dignosed drug-induced urticaria, induced urticaria (cold urticaria, febrile urticaria, cholinergic urticaria), urticaria vasculitis and other skin diseases with urticaria-like manifestations;
2. patients who have been treated well with antihistamines or have been treated with hormones, immunosuppressants, or biological agents, or have received relevant Chinese medicine treatment 1 week before enrollment,or Patients who have received antibiotics and non-steroidal anti-inflammatory drugs 2 weeks before enrollment;
3. patients who are pregnant, or preparing for pregnant, or breastfeeding women;
4. patients suffering serious organic diseases of important organs such as heart, brain, liver and kidney,and those with severe primary diseases of the hematopoietic system, and those with mental illness;
5. patients allergic to the components of Chinese medicine in the research prescription.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
time for hives subsidence;Hive Severity Score;urticaria activity score;Itch Severity Score;
Secondary Outcome Measures
NameTimeMethod
Sleep disturbance score;Activity Impact Score;Dermatology Life Quality Index;
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