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Clinical study for the effect of Lian-Bai paste in the protection and treatment of acute radiodermatitis

Clinical study for the effect of Lian-Bai paste in the protection and treatment of acute radiodermatitis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018939
Enrollment
Unknown
Registered
2018-10-17
Start date
2018-10-18
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

acute radiodermatitis

Interventions

Group A:Lianbai Paste
Group B:Danru

Sponsors

the Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged=18 years; 2. Histopathologically confirmed malignant tumor patients, with initial radiotherapy; 3. Irradiation area: head and neck, armpit and chest; 4. Function of the main organs means that the following criteria are met: (1) blood routine examination shall meet the following standards (no blood or blood products transfusions, no G-CSF is performed within 14 days, ): HB=90 g/L or higher; ANC=1.5 x 10^9/L; PLT=80x10^9/L; (2) biochemical test shall meet the following standards: TBIL 45 ml/min (Cockcroft-Gault formula); 5. Voluntarily participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who suffered skin allergy; 2. Those who suffered connective tissue disease or those who have uncured scars in irradiated area; 3. Uncontrolled diabetes or serious heart, liver, kidney, hematopoietic system and neuropsychiatric disorders (heart function level 3-4, ALT and/or AST >1.5ULN, serum creatinine>1.5ULN); 4. Some other situations that may affect the conduct of the clinical study and the results.

Design outcomes

Primary

MeasureTime frame
Grade 3/4 acute radiodermatitis;

Secondary

MeasureTime frame
Dose;healing time of skin lesions;Level of pain;drug safety;

Countries

China

Contacts

Public ContactHongbing Ma

the Second Affiliated Hospital of Xi'an Jiaotong University

mhbxian@126.com+86 13991845066

Outcome results

None listed

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