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A multicenter, randomized, double-blind, placebo-controlled clinical study on the prevention of peripheral neurotoxicity of oxaliplatin by Danggui Sini granule

A multicenter, randomized, double-blind, placebo-controlled clinical study on the prevention of peripheral neurotoxicity of oxaliplatin by Danggui Sini granule

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079315
Enrollment
Unknown
Registered
2023-12-29
Start date
2023-12-31
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Peripheral neurotoxicity of oxaliplatin

Interventions

experiment group:Oxaliplatin chemotherapy combined with Danggui Sini granules.

Sponsors

Jiangsu Province Hospital on Integration Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. All the selected cases were in accordance with the diagnostic criteria of colorectal cancer and were confirmed by pathology or cytology with stage II-IV; 2. Karnofsky score above 60; 3. Aged 18-80 years; 4. No severe damage to the center of gravity, liver, kidney or hematopoietic system; 5. Volunteer to participate in clinical research and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. with any grade of peripheral neuropathy; 2. Having received chemotherapy drugs with neurotoxicity in one month, such as cisplatin, taxanes , vinblastine alkaloids or bortezomib; 3. We are receiving carbamazepine, phenytoin sodium, valproate sodium, gabapentin, pregabalin, venlafaxine, norvenlafaxine, minapram, duloxetine, tricyclic antidepressants and other drugs that may have therapeutic or preventive effects on neuropathy; 4. A history of second or third degree atrioventricular block; 5. Participate in any other clinical study of preventing and treating neurotoxicity; 6. There is a family history of hereditary/familial neuropathy; 7. Patients with severe infection; 8. Patients with mental illness; 9. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Incidence of peripheral neurotoxicity;

Secondary

MeasureTime frame
Median occurrence time of OIPN;KPS;Number of chemotherapy cycles completed;

Countries

China

Contacts

Public ContactXi Chen

Jiangsu Province Hospital on Integration Chinese and Western Medicine

cxchenxi37@163.com+86 188 5205 0673

Outcome results

None listed

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