]>
IRCT20190815044533N1 IRCT 2020-01-04 Bagheiat-allah University of Medical Sciences Efficacy of Thyme in Metabolic syndrome Studying the efficacy of Thymus vulgaris extract in controlling Metabolic syndrome components in patients referred to Baqiyatallah hospital 2020-01-21 anticipated 200 Complete https://irct.ir/trial/41550 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Each drug package (including 100 boxs of Thymus vulgaris extract capsule and 100 boxs of placebo capsule which are absolutely same in all characters except effective material and packed in same boxs) previously superscribed with an equivalent 4-digit code using computerized randomization. The computerized randomization will done using " Random allocation software 2.0 ® " for Windows 7 ®. We will produce a simple randomized list for a sample size of 200 subjects into two groups of cases with equal size. The output code is numeric with the length of four digit. The software will printed the random four-digit codes that are matched with case or placebo group. These codes will be saved in a secret file in computer. Nobody could understand the type of drug from its shape, box or code except the analyzer at the end of trial using the secret file. Each patient who enter to trial will be given a drug box and the 4-digit code will register in his/her folder, Blinding description: A drug box with a four-digit code will allocate to each patients.these box are exactly same. the placebo and extract capsules are also same in shape, size and color. Nobody could understand the type of drug from its shape, box or code. These codes are randomly matched with placebo or case groups by the computerized randomization. All patients , the practitioner, assessor who collect informations in both visits will be blind. Only the analyzer will have access the group of patients at the end of trial. 3 Condition 1: Metabolic syndrome. Condition 2: Hyperlipidemia. Condition 3: Overweight and obesity. Condition 4: هایپرتنشن اولیه. Condition 5: Type 2 diabetes mellitus with hyperglycemia. Intervention 1: Intervention group: Thymus vulgaris extract capsule 500 mg twice aday for 12 weeks which will be donate by Barij essence drug company . Intervention 2: Control group: Placebo capsule (which is same in shape ، color , size and smell with orginal drug ) twice aday for for 12 weeks which will be donate by Barij essence drug company . Yes - There is a plan to make this available What will be shared: Personal informations are not published. We will publish the information after statistical analysis. When: The patients file information and data could be accessed just in a short periods of time during statistical analysis presumably 2 months in summer 2020. To whom: The data analyzer during statistical analysis and the practiotioner during entering the information could have access to information . Conditions: The information will be accessed by analyzer in a short period of time with a 4-digit code without any name. the information will used just with informed consent of patients and just after statistical analysis. Where to obtain: The informations will file in archive administration of Baqiyatallah hospital. How to obtain: In order to reach the patients Folders which are archived , person should refer to protective administration for recieving allowance letter . Comments:
public Hamid Babahosseini
No 2135 - 13th floor - Block 2 - phase 2 - Ekbatan
Tehran Iran (Islamic Republic of) 1396853481 +98 21 4466 9612 hbabahosseini@gmail.com Tehran University of Medical Sciences scientific Hamid Babahosseini
No 2135 - 13th floor - Block 2 - phase 2 - Ekbatan
Tehran Iran (Islamic Republic of) 1396853481 +98 21 4466 9612 hbabahosseini@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Having at least 3 of the following 5 conditions for diagnosing Metabolic syndrome according to "American Heart Association the National Heart, Lung, and Blood Institute (NHLBI)AHA/NHLBI criteria" including: 1)Elevated fasting glucose: Equal to or greater than 100 mg/dL or use of medication for hyperglycemia 2)Elevated waist circumference: Men – greater than 102 cm and Women – greater than 88 cm 3)Elevated triglycerides: Equal to or greater than 150 mg/dL 4)Reduced HDL cholesterol:Men – Less than 40 mg/dL and Women – Less than 50 mg/dL 5) Elevated blood pressure: Equal to or greater than 130/85 mm Hg or use of medication for hypertension 20 years 65 years Both History of coronary artery disease, previous angioplasty or CABG, congenital heart disease and heart failure Drug history of anti hypertension drugs or other drugs which increase or decrease the blood pressure History of liver disease , hepatitis , cirrhosis, alcohol abuse, using hepatotoxic drugs within 6 months ago Kidney disease (such as CKD , nephrotic and nephritic syndrome , AKI، kidney artery stenosis ) Thyroid dysfunction and using levothyroxine Using anti hyperlipidemic agents Using anti diabetic agents and insulin Pregnancy and lactation Psychiatric disorders which impaired regular drug using History of active cancer or treatment with chemotherapic drugs Hypersensitivity to thyme and its ingredients History of bariatrics surgery E88.81 E78.2 E66 I10 E11.65 Metabolic syndrome Mixed hyperlipidemia Overweight and obesity Essential (primary) hypertension Type 2 diabetes mellitus with hyperglycemia Treatment - Drugs Placebo Intervention group: Thymus vulgaris extract capsule 500 mg twice aday for 12 weeks which will be donate by Barij essence drug company . Control group: Placebo capsule (which is same in shape ، color , size and smell with orginal drug ) twice aday for for 12 weeks which will be donate by Barij essence drug company . Systolic and Diastolic arterial pressure. Timepoint: Beginning of study and then 12 weeks later. Method of measurement: With a "Calibrated handheld pressure gauge". Serum Fasting Blood Glucose. Timepoint: Beginning of study and then 12 weeks later. Method of measurement: Laboratory measurement of Serum sample Fasting blood glucose. Waist circumference. Timepoint: Beginning of study and then 12 weeks later. Method of measurement: Measurement of waist circumference using a Tape measure in the level of umbilicus. Serum Triglyceride level. Timepoint: Beginning of study and then 12 weeks later. Method of measurement: Laboratory measurement of Serum sample Teriglyceride level. Serum high dense lipoprotein (HDL) level. Timepoint: Beginning of study and then 12 weeks later. Method of measurement: Laboratory measurement of Serum sample High dense lipoprotein (HDL). Bagheiat-allah University of Medical Sciences Approved 2019-12-10 ٍٍEthics committee of Baqiyatallah University of Medical Sciences Molla Sadra street. - Baqiyatallah University of Medical Sciences - ٍEthics in research committee Tehran Tehran Iran (Islamic Republic of)