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External application of Longteng Tongluo Formula (LTF) for the treatment of chemotherapy-induced peripheral neuropathy: a multi-center, randomized, double-blinded placebo-controlled clinical trial

External application of Longteng Tongluo Formula (LTF) for the treatment of chemotherapy-induced peripheral neuropathy: a multi-center, randomized, double-blinded placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024617
Enrollment
Unknown
Registered
2019-07-19
Start date
2019-08-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

Tumor-related peripheral neuropathy

Interventions

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Malignant tumor diagnosed by histopathology; (2) >= Grade1peripheral neurotoxicity (including paresthesia and neuropathic pain)afterchemotherapy with oxaliplatin (with or without other chemotherapy regimen), and no planned chemotherapy within 1 month after enrollment; (3) KPS >= 70, PS score <= 2; (4) Male or female, aged 18 to 80 years; (5) No mental disorders, normal language ability and selfjudgement onpain, general conditionsand quality of life; (6) Understand this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Critically ill patients with severe pain elsewhere. (2) Symptomaticbrain metastasis or other neurological symptom due to metastasis. (3) Neuropathy caused by electrolyte disturbance and other severe systemic diseases, such as diabetes, cervical spondylosis, disc compression. (4) Skin lesionsof hand or foot. (5) History of allergic reaction to external medication. (6) History of drug abuse or addiction.

Design outcomes

Primary

MeasureTime frame
Grade of peripheral neurotoxicity;

Secondary

MeasureTime frame
The degree of pain;onset time;Quality of life evaluation;Observation of TCM syndrome;Safety;Correlation analysis of cumulative dose and adverse reactions;Serum NGF level;

Countries

China

Contacts

Public ContactShi Jun

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

shijundoctor@163.com+86 13917311112

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026