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Transformation Research of Wenluotong: a randomized controlled trial

Preclinical transformation research of external use Wenluotong Particles: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023862
Enrollment
Unknown
Registered
2019-06-15
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

Peripheral neuropathy

Interventions

Herbal medicine group:Wen-luo-tong
Control group:Placebo

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with malignant tumor diagnosed by pathology or cytology; 2.PN=1(NCI-CTCAE V5.0) induced by chemotherapy/target therapy 3.Aged 18 to 80 years; 4.ECOG score: 0-2; 5.Estimated survival period=3 months; 6.No major organ dysfunction, heart, liver, kidney function is normal, laboratory indicators to achieve the following requirements:neutrophils>1.5×10^9/L; platelet90g/L; bilirubin is normal or<1.5×ULN; AST/ALT<2.5×ULN; Serum creatinine<1.5×ULN, endogenous creatinine clearance (CCR)=60 ml/min (calculated by Cockcroft-gault formula); 7.Able to understand the situation of this study, be able to coordinate with the assessment of PN grading, and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Diagnosed with PN induced by other original disease, such as diabetes induced PN, etc.); 2.Diagnosed with other skin disease, such as hand-foot syndrome induced by Xelox(Oxaliplatin+capecitabine)chemotherapy; 3.Received other medication that may affect PN; 4.Has serious, uncontrolled organic lesions or infections; 5.Pregnant or lactating women; 6.Currently or within 4 weeks of participating in other clinical trials; 7.A clear neurological and psychiatric history, including dementia that may affect understanding and informed consent.

Design outcomes

Primary

MeasureTime frame
Total effective rate of PN;

Secondary

MeasureTime frame
Symptom remission rate;Quality of life;Sensory nerve function;Efficacy of anticancer therapy;

Countries

China

Contacts

Public ContactDeng Bo

China-Japan Friendship Hospital

elisedeng@hotmail.com+86 010-84205717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026