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IRCT20211211053359N1 IRCT 2022-09-26 Babol University of Medical Sciences Evaluation of the effect of Atorvastatin in diabetic type 2 patients in the morning and evening Evaluation of the effect of Atorvastatin administration time in the morning and evening on lipid profile in patients with type 2 diabetes 2022-09-21 anticipated 76 Complete https://irct.ir/trial/60631 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by permuted block design. The size of the blocks is 4.In each block equal number of intervention (Administer medicine in the morning) and control (Administer medicine in the evening) are placed. Sequence production for randomization will be done by a statistician and using the www.sealedenvelope.com website. Envelopes of the same shape will be prepared and in closed envelopes, the time of receiving the medicine (morning / evening) is specified, the order of these envelopes will be determined using random blocks and through the www.sealedenvelope.com website. To hide the treatment process, envelopes of the same shape are prepared according to the number of people to be studied. Three-digit codes are written on the envelopes. After each person enters the study, to allocate his treatment time, one of these envelopes (in a specific order) is given to that person by the secretary and the code on the envelope is recorded on the patient's file. At the end of the study, the codes will be reopened, Blinding description: Blindness Due to the nature of treatment in which the time of use is different (For some patients it will be prescribed in the morning and for others in the evening) blinding patients is not possible. Due to the process and method of randomization ,The person who will be blind during the study is the assessor , the assessor does not know the time of drug administration.. Therefore, this study is out come assessor blind. N/A Evaluation of the effect of Atorvastatin administration time in the morning and evening on lipid profile in patients with type 2 diabetes. Intervention 1: Intervention group:In this randomized clinical trial, participants will be randomly assigned to two separate groups in the first group of atorvastatin tablets produced by Sobhan Pharmaceutical Company will be prescribed once in the morning, the dose will be determined based on the risk of cardiovascular complications in each individual, after 4 weeks the level of blood lipids will be measured again. Intervention 2: Control group: in the second group of atorvastatin tablets produced by Sobhan Pharmaceutical Company will be prescribed once in the evening, the dose will be determined based on the risk of cardiovascular complications in each individual, after 4 weeks the level of blood lipids will be measured again. 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 No more information
public Sepide Tavanaeifard
Ayatollah Rouhani Hospital., Ganjafrooz St., University Square., Babol Town., Mazandaran Province
Babol Iran (Islamic Republic of) 4717647745 +98 11 3223 8301 s.tavanaeifard@mubabol.ac.ir Babol University of Medical Sciences scientific Sepide Tavanaeifard
Ayatollah Rouhani Hospital., Ganjafrooz St., University Square., Babol Town., Mazandaran Province
Babol Iran (Islamic Republic of) 4717647745 +98 11 3223 8301 s.tavanaeifard@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Any diabetic patient over the age of 40 40 years no limit Both People with renal failure Patient with cancer People who have used lipid lowering drugs before Treatment - Drugs Treatment - Drugs Intervention group:In this randomized clinical trial, participants will be randomly assigned to two separate groups in the first group of atorvastatin tablets produced by Sobhan Pharmaceutical Company will be prescribed once in the morning, the dose will be determined based on the risk of cardiovascular complications in each individual, after 4 weeks the level of blood lipids will be measured again. Control group: in the second group of atorvastatin tablets produced by Sobhan Pharmaceutical Company will be prescribed once in the evening, the dose will be determined based on the risk of cardiovascular complications in each individual, after 4 weeks the level of blood lipids will be measured again. Blood levels of lipid profiles. Timepoint: At the beginning of the study and after 4 weeks. Method of measurement: Blood lipid profile (TG, HDL, LDL). Gastrointestinal complication. Timepoint: At the beginning of the administration of the drug on a daily basis. Method of measurement: Gastrointestinal complications will be recorded by the patients in the corresponding checklist on a daily basis. Musculoskeletal complications. Timepoint: At the beginning of the administration of the drug on a daily basis. Method of measurement: Musculoskeletal complications will be recorded by the patients in the corresponding checklist on a daily basis. Babol University of Medical Sciences Approved 2022-02-06 Ethics committee of babol University of Medical Sciences Ganjafrooz St., University Square., Babol Town., Mazandaran Province Babol Mazandaran Iran (Islamic Republic of)