Evaluation of the efficacy and side effects of Black seed Oil in the treatment of peripheral neuropathy caused by oxaliplatin; a randomized, double-blind, placebo-controlled clinical trial

Evaluation of the efficacy and side effects of Black seed Oil in the treatment of peripheral neuropathy caused by oxaliplatin

A Clinical trial with two parallel groups, with a control group, with placebo, double-blind, phase 3, with a sample size of 56 people. Randomization with the help of Excel software and quadruple blocks.

In order to investigate the therapeutic effect of black seed oil in peripheral neuropathy caused by oxaliplatin, which is performed at Imam Khomeini Hospital in Sari. This study has two arms, drug and placebo, and a four-digit code is assigned to each patient through the Excel program.

Inclusion criteria: Patients with chemotherapy-induced peripheral neuropathy (CIPN) grade 2 and 3 according to NCI CTCAE v5.0 criteria and patients over 18 years of age will be included in the study. Exclusion criteria: Patients with previous history of neurological diseases, neuropathic pains, severe liver failure, heavy alcohol users, simultaneous use of vitamin B1, B6 and B12 and supplements containing calcium and magnesium during the previous two weeks, Taking medications related to peripheral neuropathy such as gabapentin, pregabalin, venlafaxine, using topical analgesic products, history of diabetes, pregnant and lactating.

Intervention group: black seed oil capsule 1000 mg, once a day for the first week and then twice a day for 7 weeks (8 weeks in total) along with duloxetine placebo. Control group: duloxetine 30 mg capsules, once daily for the first week and then twice for 7 weeks (8 weeks in total) along with black seed oil placebo.

severity of peripheral neuropathy; pain intensity; Quality of Life

The randomization process for assigning participants to receive either black seed oil or duloxetine will be conducted using Block Balanced Randomization (BBR). To ensure allocation concealment, a four-digit random number will be generated using a random number table to serve as each participant’s unique identification code, keeping the group assignment (A or B) concealed. Participants will be randomized in blocks of four into two groups: "black seed oil and duloxetine placebo" and "duloxetine and black seed oil placebo". Only the primary investigator will have access to the block information and the unique codes assigned to each participant. The medication and corresponding placebo will be pre-packaged according to the assigned codes and distributed to participants based on the randomization results. Arrangements will be made to ensure that patients receive Barij black seed oil and duloxetine manufactured by Abidi Pharmaceutical Company.

This study will be conducted in a double-blind manner, meaning that the patient, the physician, and the clinical evaluator will all be unaware of the intervention received (either black seed oil or duloxetine). The medications and placebos will be prepared by a pharmaceutical company and provided to the patients in identical packaging labeled with the four-digit code.

there is no plan for publishing the protocol of study because it is accessible in IRCT

All data are shareable after publishing

Start the access period 6 months after publishing the result

All researchers

for used in clinical practice and also future meta-analysis

Ebrahim Salehifar Email: Esalehifar52@gmail.com

sending email to Dr Ebrahim Salehifar