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IRCT20210612051544N1 IRCT 2021-08-16 Ahvaz University of Medical Sciences The effect of Grape seed on the control of blood sugar, blood lipids and blood pressure. The effect of Grape seed extract on Fasting blood glucose, Lipid profile and Blood pressure in patients with type 2 diabetes mellitus; A randomized double blind clinical trial. 2021-08-23 anticipated 80 Complete https://irct.ir/trial/56874 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the randomization method of permutation blocks. In this two-group clinical trial, the size of blocks 4, 6 and 8 is considered (in this method, the number of people assigned to each group in the blocks is equal). For concealment, we use concealment allocation, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using opaque, sealed, numbered sequentially sealed non-transparent envelopes (envelopes opaque, sealed, numbered sequentially) in which in this method each random sequence is recorded on a card and the cards are placed in the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed. Randomization list using PLAN procedure in the software SAS is generated, Blinding description: In this study, patients do not know the type of drug (placebo or herbal pill ..). The patient evaluator is also not aware of the type of treatment assigned to patients so that patients can be evaluated without any bias. Therefore, this study will be performed based on the two-blind method. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: Grape seed extract, grape seed extract 263.2 mg, two tablets daily, duration of use 30 days, Shari Pharmaceutical Supplement Company. All patients are asked to continue their previous medications to control their blood sugar, fat, and blood pressure during the study period, according to their doctor, and should not change their dose during the study. Intervention 2: Control group: placebo tablets (containing starch), 263.2 mg, two daily, duration of use for 30 days, Shari Pharmaceutical Supplement Company. All patients are asked to continue their previous medications to control their blood sugar, fat, and blood pressure during the study period, according to their doctor, and should not change their dose during the study. 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 There is no more information
public Mehrnoosh Zakerkish
Ahvaz ,Golestan Hospital, Internal Ward
Ahvaz Iran (Islamic Republic of) 6135715794 0098613374013 zakerkish-m@ajums.ac.ir Ahvaz University of Medical Sciences scientific Mehrnoosh Zakerkish
Ahvaz Golestan Hospital Internal Ward
Ahvaz Iran (Islamic Republic of) 6135715794 0098613374013 zakerkish-m@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 25_80 years HbA1C 7%_8/5% FBS 126_200 mg/dl Diabetes diagnosis period less than 10 years Patients use only oral hypoglycemic drugs BMI less than 35 25 years 80 years Both Breastfeeding_ pregnancy Insulin therapy Obvious renal and hepatic insufficiency { Obvious renal failure with CLCr less than 30 and obvious hepatic insufficiency with ALT or AST more than 100 } diabetes diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: Grape seed extract, grape seed extract 263.2 mg, two tablets daily, duration of use 30 days, Shari Pharmaceutical Supplement Company. All patients are asked to continue their previous medications to control their blood sugar, fat, and blood pressure during the study period, according to their doctor, and should not change their dose during the study. Control group: placebo tablets (containing starch), 263.2 mg, two daily, duration of use for 30 days, Shari Pharmaceutical Supplement Company. All patients are asked to continue their previous medications to control their blood sugar, fat, and blood pressure during the study period, according to their doctor, and should not change their dose during the study. TG. Timepoint: At the beginning of the intervention and 30 days after taking Grape seed. Method of measurement: Blood test. Cholesterol. Timepoint: At the beginning of the intervention and 30 days after taking Grape seed. Method of measurement: Blood test. HDL. Timepoint: At the beginning of the intervention and 30 days after taking Grape seed. Method of measurement: Blood test. LDL. Timepoint: At the beginning of the intervention and 30 days after taking Grape seed. Method of measurement: Blood test. FBS. Timepoint: At the beginning of the intervention and 30 days after taking Grape seed. Method of measurement: Blood test. Systolic blood pressure. Timepoint: At the beginning of the intervention and 30 days after taking Grape seed. Method of measurement: Sphygmomanometer. Diastolic blood pressure. Timepoint: At the beginning of the intervention and 30 days after taking Grape seed. Method of measurement: Sphygmomanometer. Ahvaz University of Medical Sciences Approved 2021-04-13 Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences and He Golestan Blvd., Shahrestaneshgahi, Esfand St., Ahvaz Jundishapur University of Medical Sciences, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Health Services, Ground Floor Ahvaz Khouzestan Iran (Islamic Republic of)