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COMPLETED
NCT07614243
NA

Long Non-coding RNA (lncRNA) ZFAS1-Mediated Mechanism of Roasted Nux Vomica in Intervening Bortezomib-Induced Peripheral Neuropathy

Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of Roasted Nux Vomica Capsules in the treatment of BIPN in patients with multiple myeloma. A total of 22 patients with multiple myeloma who developed peripheral neuropathy after receiving bortezomib-based chemotherapy will be enrolled at the First Affiliated Hospital of Zhejiang Chinese Medical University. All patients will receive oral Roasted Nux Vomica Capsules at a dose of 0.4 g three times daily for 6 consecutive weeks. The researchers will assess the severity of peripheral neuropathy assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, traditional Chinese medicine symptom (TCM) scores, and neurotoxicity scores measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTx) scale at baseline (before treatment) and at 2, 4, and 6 weeks after starting treatment. The study will also explore the underlying mechanism of Roasted Nux Vomica in treating BIPN through the lncRNA ZFAS1 pathway. This study has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (Approval Number: 2021-K-263-01).

Official title: Study on the Intervention Effect of Roasted Nux Vomica on Bortezomib-Related Peripheral Neuropathy Based on lncRNA ZFAS1

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2020-08-01

Completion Date

2022-08-31

Last Updated

2026-05-29

Healthy Volunteers

No

Interventions

DRUG

Roasted Nux Vomica Capsules

Roasted Nux Vomica Capsules is a hospital preparation approved by Zhejiang Provincial Medical Products Administration (Approval No.: Zhe Yao Zhi Zi Z20100263). Each capsule contains 0.2 g of processed Strychnos nux-vomica L. seed powder. Patients take 2 capsules (0.4 g) orally three times daily with warm water after meals for 6 consecutive weeks. All patients continue their original bortezomib-based chemotherapy regimen during the study period.

Locations (1)

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)

Hangzhou, Zhejiang, China