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

A clinical study on the prevention and treatment of peripheral neurotoxicity of oxaliplatin by Danggui Sini granule

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000004124
Enrollment
Unknown
Registered
2020-12-01
Start date
2020-12-01
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

Peripheral neurotoxicity of oxaliplatin

Interventions

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, the predicted survival time was more than 4 months; 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 oxaliplatin, cisplatin, taxanes or vinblastine alkaloids; 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 women.

Design outcomes

Primary

MeasureTime frame
NCI-CTCAE 4.0;

Secondary

MeasureTime frame
EORTC QLQ-CIPN20;The function of median nerve and peroneal nerve was detected by electromyography;KPS;

Countries

China

Contacts

Public ContactRong Ding

Jiangsu Province Hospital on Integration Chinese and Western Medicine

gracedr78@sina.com+86 025-85637121

Outcome results

None listed

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