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IRCT20090613002027N24 IRCT 2025-04-20 Mazandaran University of Medical Sciences The effect of Black seed oil on oxaliplatin neuropathy 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 2025-05-10 anticipated 56 Complete https://irct.ir/trial/79307 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Peripheral neuropathy. Intervention 1: Intervention group: Black seed oil capsule 1000 mg, daily for the first week and then twice a day for 7 weeks (8 weeks in total) along with duloxetine placebo. Intervention 2: Control group: Duloxetine 30 mg capsules, daily for the first week and then twice a day for 7 weeks (8 weeks in total) along with black seed oil placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no plan for publishing the protocol of study because it is accessible in IRCT
public Ebrahim salehifar
faculty of pharmacy, payambar azam complex, 18 km farah abad Blvd, khazar square
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3083 Esalehifar@mazums.ac.ir Mazandaran University of Medical Sciences scientific Ebrahim salehifar
Faculty of pharmacy , Payambar Azam complex, 18 km farah abad blvd, Khazar square
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3083 Esalehifar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) People over the age of 18 Patients with chemotherapy-induced peripheral neuropathy (CIPN) grade 2 and 3 according to NCI CTCAE v5.0 criteria 18 years no limit Both Patients with previous history of neurological diseases such as hereditary and acquired neuropathies Patients with neuropathic pain due to conditions such as postherpetic neuralgia, uncontrolled diabetes with neuropathy, trigeminal neuralgia, spinal cord injury or other neurological diseases, known vitamin B12 deficiency, amyloidosis, neuromuscular diseases and connective tissue diseases Severe liver failure (liver enzymes more than three times the normal limit) History of diabetes History of alcohol consumption Simultaneous use of vitamins 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 Use of topical analgesic products Taking antiepileptic drugs Pregnant or lactating women Lack of consent to participate in the study G63 Polyneuropathy in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: Black seed oil capsule 1000 mg, daily 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, daily for the first week and then twice a day for 7 weeks (8 weeks in total) along with black seed oil placebo. Severity of neuropathy. Timepoint: at baseline and week 2, week 4 and the end of week 8 after taking the drug. Method of measurement: Based on NCI CTCAE version 5, FACT/GOG-Ntx, Neuropathy pain scale, Patient Neurotoxicity Questionnaire. Intensity of pain. Timepoint: at baseline and week 2, week 4 and the end of week 8 after taking the drug. Method of measurement: based on Numeric pain rating scale. Quality of life. Timepoint: at baseline and the end of week 8 after taking the drug. Method of measurement: based on EORTC QLQ-C30 version 3. Mazandaran University of Medical Sciences Approved 2025-04-06 Mazandaran Medical University Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square, Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)