Peripheral neuropathy. Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
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
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: People over the age of 18 Patients with chemotherapy-induced peripheral neuropathy (CIPN) grade 2 and 3 according to NCI CTCAE v5.0 criteria
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEbrahim salehifar
Mazandaran University of Medical Sciences
Outcome results
None listed