Studying the efficacy of Thymus vulgaris extract in controlling Metabolic syndrome components in patients referred to Baqiyatallah hospital

Studying the efficacy of Thymus vulgaris extract in controlling dyslipidemia,systolic and diastolic hypertension,insulin resistance and abdominal obesity in Metabolic syndrome patients.

This study is a randomized, placebo-controlled, double-blind, phase 3 clinical trial with two parallel groups. Two hundred Metabolic syndrome patients who have eligibility criteria will be selected and randomely divided into case and placebo groups using computerized randomization and followed for twelve weeks .

This trial will be done in Heart Clinic of Baqiyatallah hospital. The Metabolic syndrome patients who have the eligibility criteria will selected and after taking history, physical exams and required laboratory test , drug package(Thyme extract or placebo capsule) will be given and followed for twelve weeks and then all exams and tests will be repeated.

Inclusion criteria: 20 to 65 years old Metabolic syndrome patients who have more than three of five conditions according to "American Heart Association/the National Heart, Lung, and Blood Institute (AHA/NHLBI) criteria". Exclusion criteria: History of cardiac, hepatic, kidney, thyroid and psychiatry disease; Drug history of antihypertensive, antihyperlipidemic, hepatotoxic and antidiabetic drugs ; Pregnancy and lactation ; Hypersensitivity to thyme;

Treatment group: Thymus vulgaris extract capsule 500 milligram twice a day for twelve weeks. Control group: Placebo Capsule with the same shape,size and color of original drug twice a day for twelve weeks.

Waist circumference ; Fasting blood glucose ; Systolic and diastolic blood pressure ; Serum lipid profile ;

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.

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.

Personal informations are not published. We will publish the information after statistical analysis.

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.

The data analyzer during statistical analysis and the practiotioner during entering the information could have access to information .

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.

The informations will file in archive administration of Baqiyatallah hospital.

In order to reach the patients Folders which are archived , person should refer to protective administration for recieving allowance letter .