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A randomized, double-blind, controlled clinical trial of Duopi Yin in the treatment of chronic refractory urticaria

A randomized, double-blind, controlled clinical trial of Duopi Yin in the treatment of chronic refractory urticaria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071699
Enrollment
Unknown
Registered
2023-05-23
Start date
2023-05-27
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic urticaria

Interventions

Test group:Take duopiyin granules and simulation of desloratadine citrate capsules
control group:Take simulation of duopiyin granules and desloratadine citrate capsules

Sponsors

Beijing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Only those who meet all of the following items can join the group: 1) Comply with the diagnostic criteria of chronic refractory urticaria in Chinese and Western medicine; 2) Men and women aged 18-65; 3) The course of disease lasts more than 6 months; 4) The patient who has been treated with second-generation antihistamines for more than 2 weeks in the past six months cannot be completely controlled; 5) In recent half a year, the syndrome differentiation of traditional Chinese medicine was wind cold syndrome, wind heat syndrome or blood deficiency and wind dryness syndrome. After treatment by syndrome differentiation, the improvement of skin lesions was not obvious after 2 weeks of regular medication; 6) Participate in the study voluntarily and sign the informed consent; 7) UAS7=16, and UAS=4 assessed by doctors at least once before enrollment 1 week.

Exclusion criteria

Exclusion criteria: 1) Patients with other pruritus causing skin diseases, serious condition, affecting the assessment of pruritus symptoms; 2) Patients with active stage of severe autoimmune diseases such as systemic lupus erythematosus; 3) Pregnant and lactating women; 4) Patients with severe primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems and mental diseases; 5) Failure in safety examination (kidney function or liver function greater than 1.5 times the upper limit of normal value); 6) Systematic use of immunosuppressants or hormones within 3 months or biological agents within 6 months 7) Patients who are currently enrolled in or have participated in other urticaria clinical studies within the month prior to this study; 8) The patient is a researcher directly involved in this study; 9) The researcher determined that there were other conditions that were not appropriate to participate in the clinical trial.

Design outcomes

Secondary

MeasureTime frame
chronic urticaria quality of life questionnaire;Urticaria Control Test;

Primary

MeasureTime frame
weekly urticaria activity scores;

Countries

China

Contacts

Public ContactHuiting Zhu

Beijing Hospital of Traditional Chinese Medicine

47200680@qq.com+86 133 6640 5565

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026