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IRCT20170608034390N12 IRCT 2022-12-09 Shahid Beheshti University of Medical Sciences Evaluating the Efficacy of Crocin on Movement Disorders and Neuronal Oxidative Stress of Parkinson's Disease Evaluating the Efficacy of Crocin on Movement Disorders and Neuronal Oxidative Stress of Parkinson's Disease; A Double-blind, Randomized, Placebo-controlled Clinical Trial 2022-11-22 anticipated 54 Complete https://irct.ir/trial/64977 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will randomly divide the participants into two groups with the same size of 27 participants (54 patients in total), to ensure the equal distribution of patients in the two groups, the block randomization method will be used, and 9 blocks of 6 people in total will be created. Sealed Envelope online software will be used to create random codes. Patients who meet the inclusion criteria receive the code in order and based on the grouping of random blocks, for example, the distribution and coding in the first block is as follows, the first patient Group A, the unique code is ZX6, the second patient Group A, the unique code is GA6, Group B third patient, FR9 code, Group B fourth patient, PP3 code, Group A fifth patient, FR9 code, Group B sixth patient, AE8 code. The number of patients in groups A and B in each block is equal, but the random sequence will be different, Blinding description: After preparing the medicine and placebo, they will be packed in the same box by a clinical laboratory expert who is outside the researchers and will be provided with random codes based on the Excel file extracted from the Sealed Envelope software. The package will be transported to the clinic and the codes will closed till the statistical analysis is performed. 3 Parkinson's disease. Intervention 1: Intervention group: Patients will take an oral capsule containing 30 mg of crocin in the morning and evening for 8 weeks. Granules containing crocin were obtained from Sami Saz Pharmaceutical Company in Mashhad and filled in capsules in the pharmaceutical pilot production laboratory located in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences under GMP conditions. The medicine was filled in capsules and in white polyethylene jars was packed in 60 pieces. Intervention 2: Placebos were filled in the pilot production laboratory of the Faculty of Pharmacy, located in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, under GMP conditions, in oral capsules with the same color and shape as the study product (intervention group), the capsules were filled and placed in white polyethylene jars. Packed in 60 capsules. Patients will take one in the morning and one in the evening for 8 weeks. Yes - There is a plan to make this available What will be shared: potentially the whole data will be published after participants become unidentified When: The data will be available 6 months after data publish. To whom: Industrial and Academic Researchers Conditions: To carry out further research Where to obtain: Dr. Hadi Esmaily, School of Pharmacy, Shahid Beheshti University of Medical Sciences. How to obtain: It can be provided by sending a request by email. Email to the person in charge of the study: Esmaily_hadi@sbmu.ac.ir Comments:
public Hadi Esmaily
Shahid Beheshti School of Pharmacy, Vali Ars AVe
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8887 3704 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Hadi Esmaily
Shahid Beheshti School of Pharmacy, Vali Ars AVe
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8887 3704 Esmaily_hadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Idiopathic Parkinson's patients Age 30 to 80 years No change in diet, medication and supplements during 8 weeks They declare their agreement to participate in the clinical trial through a written consent form 30 years 80 years Both Patients with a history of saffron allergy Patients with severe episodes of wearing off Consumers of saffron more than 1 gram per day Taking warfarin, monoamine oxidase inhibitors Pregnant and lactating patients Liver disease Occurrence of urticaria complications; skin itching; Nausea and vomiting and dizziness Patients with severe Hoehn and Yahr stage 5 Parkinson's disease G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Patients will take an oral capsule containing 30 mg of crocin in the morning and evening for 8 weeks. Granules containing crocin were obtained from Sami Saz Pharmaceutical Company in Mashhad and filled in capsules in the pharmaceutical pilot production laboratory located in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences under GMP conditions. The medicine was filled in capsules and in white polyethylene jars was packed in 60 pieces. Placebos were filled in the pilot production laboratory of the Faculty of Pharmacy, located in the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, under GMP conditions, in oral capsules with the same color and shape as the study product (intervention group), the capsules were filled and placed in white polyethylene jars. Packed in 60 capsules. Patients will take one in the morning and one in the evening for 8 weeks. Unified Parkinson's Disease Rating Scale (UPDRS). Timepoint: At the beginning and eight weeks after the start of the study. Method of measurement: Unified Parkinson's Disease Rating Scale (UPDRS) Questionnaire. Malondialdehyde reduction in blood (oxidative stress biomarker). Timepoint: The beginning of the study and the end of the study. Method of measurement: Spectrophotometry. Shahid Beheshti University of Medical Sciences Approved 2022-06-21 Research Ethics Committee School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Valiasr Tehran Tehran Iran (Islamic Republic of)