IRCT20120215009014N501 IRCT 2024-02-29 Hamedan University of Medical Sciences Effects of topical gel Silymarin versus placebo as an adjuvant therapy on pain management in patients with painful diabetic neuropathy Effects of topical gel Silymarin versus placebo as an adjuvant therapy on pain management in patients with painful diabetic neuropathy: a double-blind randomized clinical trial 2024-03-25 anticipated 50 Complete https://irct.ir/trial/75731 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached, Blinding description: Both the medications and placebos will have the same shape. Consequently, patients will remain unaware of the type of intervention they receive. Moreover, the randomization process will be conducted by a separate individual from the one who examines the patients, ensuring that the examining person remains unaware of the intervention. The analyzer responsible for evaluating the trial's results will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a double-blind study. 3 Painful diabetic neuropathy. Intervention 1: Intervention group: Pregabalin 75 mg tablet at night plus 3% silymarin topical gel twice a day for 2 months. Intervention 2: Control group: Pregabalin 75 mg tablet at night plus placebo topical gel twice a day for 2 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situation and the results of the study as well as the approval of the financial supporting organization.