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IRCT20180119038433N1 IRCT 2018-12-28 Semnan University of Medical Sciences The effect of saffron on patients with chemotherapy-induced neuropathy The effect of Crocus sativus L. (saffron) on patients with chemotherapy-induced neuropathy; A clinical trial 2018-12-22 anticipated 60 Complete https://irct.ir/trial/35775 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is a simple, individual and by random numbers Accidental assignment to intervention and control groups, Blinding description: Medications will be coded by a third person (outside the study) (e.g., the main treatment group number 1, placebo # 2, and positive control # 3). Then the stickers of the medications are removed and the number of drugs will be available to the student (responsible for the correct follow-up and administration of the medications). Student sees only the number and does not know the type of medicine. The patient merely knows that she will be given a study that will help her treatment and is completely unaware of the prescription of the drug. After administering the drugs and registering the data by the student, the information is provided to the statistical analyst (which he knows only the number and does not know the type of medication). After statistical analysis, the data will be available to the researcher responsible for writing the article. In order to write the article, the main researcher will also use the third person (outside the study) to match the type of medication. N/A Chemotherapy-induced nephropathy. Intervention 1: Patients with chemotherapy-induced neuropathy receiving a 15 mg tablet of saffron (crocin) daily up to 3 months (produced by Mashhad University of Medical Sciences). Intervention 2: Control group: Patients with chemotherapy-induced neuropathy receiving 1 placebo tablet per day for 3 months. Intervention 3: Control group: Patients with chemotherapy-induced neuropathy receiving a 100 mg capsule of gabapentin daily for 3 months (positive control group). 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 Because of uncertainty about the provision of the necessary conditions, for example, the cooperation of patients
public Hooman bozorgi
Damghan road-Semnan University of Medical Sciences
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2001 hoomanbozorgi@semums.ac.ir Semnan University of Medical Sciences scientific Hooman bozorgi
Damghan road-Semnan University of Medical Sciences
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2001 hoomanbozorgi@semums.ac.ir Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with chemotherapy-induced neuropathy no limit no limit Both G62.0 Drug-induced polyneuropathy Treatment - Drugs Placebo Treatment - Drugs Patients with chemotherapy-induced neuropathy receiving a 15 mg tablet of saffron (crocin) daily up to 3 months (produced by Mashhad University of Medical Sciences) Control group: Patients with chemotherapy-induced neuropathy receiving 1 placebo tablet per day for 3 months Control group: Patients with chemotherapy-induced neuropathy receiving a 100 mg capsule of gabapentin daily for 3 months (positive control group) Severity of neuropathy (based on items in the questionnaire) of patients receiving chemotherapy. Timepoint: Evaluation of neuropathy in patients before administration of medication is between the administration period (day 45 after the intervention, ie the administration of the first dose, placebo and positive control) and after treatment (up to 1 month after the last administration of the intervention). Method of measurement: Nerve conduction velocity test as well as questionnaire. Life quality Score. Timepoint: Prior to prescribing, between the administration period (45 days after the intervention, ie the administration of the first dose, placebo and positive control) and after treatment (up to 1 month after the last administration of the interventions). Method of measurement: Short questionnaire 12 questions (SF12). Semnan University of Medical Sciences Approved 2018-11-20 Ethics Committee in Semnan University of Medical Sciences Damghan road-Semnan University of Medical Sciences semnan Semnan Iran (Islamic Republic of)