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Real-world study on the post-marketing reevaluation of Shiduqing Capsules/Tablets in the treatment of skin itching

Real-world study on the post-marketing reevaluation of Shiduqing Capsules/Tablets in the treatment of skin itching

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001728
Enrollment
Unknown
Registered
2026-07-13
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pruritus caused by skin diseases

Interventions

experimental group:Shiduqing Capsules/Shiduqing Tablets

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 4.2.1 Aged 18 to 75, of either gender; 4.2.2 Patients with clinically diagnosed skin itching-related diseases (including atopic dermatitis, psoriasis, urticaria, chronic eczema, nodular prurigo, neurodermatitis, and cutaneous pruritus), with a clear diagnosis of Fengshi Yunfu syndrome or Xuexu Fengzao syndrome in traditional Chinese medicine (TCM), and who have been prescribed Shiduqing by a doctor based on clinical routine diagnosis and treatment decisions; 4.2.3 Voluntarily sign the informed consent form and promise to cooperate in completing the required follow-up visits and data collection; 4.2.4 Able to articulate their own itching sensations clearly, and capable of completing the VAS scoring and questionnaire filling (or with the assistance of family members); 4.2.5 At baseline (before medication), the VAS itch score is =4 (indicating moderate or severe itch).

Exclusion criteria

Exclusion criteria: 4.3.1 Those who are allergic to any component of Shiduqing (such as Rehmannia glutinosa, Angelica sinensis, Sophora flavescens, etc.) or excipients of the preparation (such as gelatin in capsule shells, starch in tablets); 4.3.2 Combined severe organ dysfunction involving the heart, liver, kidney, hematopoietic system, etc. (e.g., ALT/AST > 2 times the upper limit of normal, Scr > 1.5 times the upper limit of normal); 4.3.3 Women who are pregnant or breastfeeding; 4.3.4 Those with a history of drug abuse, alcohol dependence, or mental illness (such as depression, schizophrenia), who are unable to cooperate with follow-up visits; 4.3.5 Those who are currently participating in other drug clinical trials or have participated in other clinical trials within the past 3 months; 4.3.6 Individuals with allergic constitution (allergic to 2 or more drugs or foods) or those who have experienced severe allergic reactions recently (within 1 month); 4.3.7 The researcher believes that there are other situations that are not suitable for inclusion (such as expected survival time < 3 months, inability to complete follow-up, incomplete data, etc.).

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale;Itch Assessment Scale;

Secondary

MeasureTime frame
Traditional Chinese Medicine (TCM) syndrome score;Body Surface Area;Physician's Global Assessment;Dermatology Life Quality Index score;Hospital Anxiety and Depression Scale;

Countries

China

Contacts

Public ContactChen Weiwen

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

chenweiwen@bjzhongyi.com18519866309

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026