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Efficacy and safety of Chinese herbal medicine Piminxiao Capsule for the treatment of chronic spontaneous urticaria (CSU) with wind-heat or wind-heat complicated by dampness: a multi-center randomized controlled trial

Efficacy and safety of Chinese herbal medicine Piminxiao Capsule for the treatment of chronic spontaneous urticaria (CSU) with wind-heat or wind-heat complicated by dampness: a multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005831
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-30
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

chronic spontaneous urticaria

Interventions

Intervention group:Piminxiao Capsule and Levcetirizine
Control group:Piminxiao Capsule

Sponsors

Jiangsu Province Hispital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Participants are included if they are aged between 18 and 60 years; clinically diagnosed with CSU, and belonging to wind-heat or wind-heat complicated by dampness according to TCM; and give written informed consent. For the diagnostic criteria of CSU, we will refer to The EAACI/GA2LEN/EDF/WAO Guideline for the definition, classification, diagnosis and management of urticaria. For the TCM diagnostic criteria, we will refer to Expert Consensus on TCM Treatment of Urticaria.

Exclusion criteria

Exclusion criteria: 1. Patients with obvious predisposing factors can be found (such as cold urticaria, stress urticaria, etc. ). 2. Patients with other diseases with urticaria or vascular edema as skin manifestations, such as hereditary vascular edema, acquired vascular edema. 3. Interventions of glucocorticoid, hydroxychloroquine, methotrexate, cyclophosphamide, cyclosporine or intravenous immunoglobulin in the previous 1 month. 4. Interventions of histamine H2 receptor antagonist or leukotriene receptor antagonist in the previous 1 week. 5. Patients who took off-label dosage levocetirizine hydrochloride or used other histamine H1 receptor antagonists in the last two weeks 6. Patients allergic to the drugs used in this study. 7. Patients with serious primary diseases of the liver or kidney systems. 8. Patients with pregnancy or lactation. 9. Other conditions that researchers believe are unsuitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Urticaria activity score, UAS;

Secondary

MeasureTime frame
Chronic Urticaria Quality of Life Questionnaire, CU-Q2oL;TCM symptom scale score;Itch severity score, ISS;Urticaria control test, UCT;

Countries

China

Contacts

Public ContactHong Shengwei
Shengwei_Hong@126.com13655219101

Outcome results

None listed

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