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Ku Qin Formula combined with dupilumab for Prurigo Nodularis: a practical randomized clinical trials

Ku Qin Formula combined with dupilumab for Prurigo Nodularis: a practical randomized clinical trials

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091414
Enrollment
Unknown
Registered
2024-10-28
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

Prurigo Nodularis

Interventions

Trial group:Dupilumab subcutaneous injection and Ku Qin Formula orally
Control group:Dupilumab subcutaneous injection

Sponsors

Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Determined to meet the diagnostic criteria of Western medicine and traditional Chinese medicine regarding Prurigo Nodularis and conform to the pattern of dampness-heat-wind-toxicity; (2) Age 18-85 years old, gender is not limited; (3) No treatment related to Prurigo Nodularis within 2 weeks before enrollment; (4) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who have participated or are currently participating in other clinical trials within the last 1 month; (2) Persons with acute infectious diseases or infections; (3) Women who are in preparation for pregnancy, pregnancy, or breastfeeding; (4) Patients with severe cardiovascular, cerebrovascular, hepatic, renal and hematopoietic system primary diseases, or psychiatric disorders; (5) Known hypersensitivity to the medication used in this treatment and intolerance to the treatment method.

Design outcomes

Primary

MeasureTime frame
Pruritus relief rate;

Secondary

MeasureTime frame
Skin lesion severity score;time to recurrence;the Dermatology Life Quality Index;Chinese Medicine Symptom Score;

Countries

China

Contacts

Public ContactWang Yifei

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

wyf_cz@163.com+86 135 1212 1732

Outcome results

None listed

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