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A Prospective, Open, Single-Arm, Multi-Center Clinical Study on the Efficacy and Safety of Pi-Yan-Ning Decoction in the Treatment of Grade III Skin Rash Induced by Anti-Tumor Targeted Drugs

A Prospective, Open, Single-Arm, Multi-Center Clinical Study on the Efficacy and Safety of Pi-Yan-Ning Decoction in the Treatment of Grade III Skin Rash Induced by Anti-Tumor Targeted Drugs

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003532
Enrollment
Unknown
Registered
2020-08-01
Start date
2020-08-01
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

Skin Rash Induced by Anti-tumor Targeted Drugs

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged >18 years; 2. Patients receiving anti-tumor targeted drugs; 3. Grade III rash according to NCI-CTC 5.0 standard; 4. KPS > 60, life expectancy >=3 months; 5. The functional level of major organs met the following criteria: 1) ANC (>= 1.5 *10^9/L), PLT (>= 75 *10^9/L), Hb (>= 80 g/L); 2) TBIL =50 ml/min) (Cockcroft-Gault formula); 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Skin lesions or skin diseases considered to affect the study, or history of allergic contact with other drugs; 2. Received hormones or antibiotics or any other drugs that may affect the skin rash within 1 week before the start of our research, including Chinese patent medicine and herbal medicine; 3. Serious or uncontrollable systemic diseases (such as unstable respiration, circulation, digestion, urinary and blood system diseases, ect.); 4. Previous history of neurological or mental disorders, including epilepsy and dementia; 5. Pregnancy or lactation; 6. The subject was considered not be able to complete the study or comply with the requirements of this study (due to management or other reasons).

Design outcomes

Secondary

MeasureTime frame
Recurrence rate;Safety evaluation;Quality of life assessment;Completion rate of original anti-tumor treatment intensity;

Primary

MeasureTime frame
Cure rate;Effective time;Partial response rate;Total effective rate;Changes of rash classification;

Countries

China

Contacts

Public ContactQijin Shu

The First Affiliated Hospital of Zhejiang Chinese Medical University

shuqjhz@163.com+86 13605706566

Outcome results

None listed

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