Comparison of the effect of fenugreek tablets (Moota) with metformin tablets in improving the clinical symptoms and metabolic status of patients with polycystic ovary syndrome (PCOS) referred to the clinics of the University of Medical Sciences

Comparison of Fenugreek Pills (Motta Pills) with Metformin in Improving Clinical Symptoms

Pre-designed questionnaire including demographic variables and laboratory variables studied First, the data are entered into SPSS software version 22 and in order to analyze the data using descriptive statistics methods including frequency distribution tables and graphs, the studied variables will be described and the expression of stratified variables will be compared through a test. Chi-square (Pearson's x2-test) will be performed and also the relationship between continuous variables and if there is a normal distribution using t-test and if there is no normal distribution using Mann-Whitney test will be examined. All tests will be reviewed at an error level of 5%.

Patients were treated with pre-determined drug packages by the study supervisor (supervisor). The forms were completed by the project manager and his assistant who were not aware of the contents of the packages; in the data analysis stage, the analysis was performed by the project consultant and the project manager who were not aware of the contents of the drug packages and only the patient group. (Group 1 or 2) was determined for data analysis.

Include: Female infertility (ovarian factor) Exclude: Use of other blood sugar control drugs

One group will use fenugreek tablets and the second group will use the common drug metformin and the two groups will be compared.

Insulin, insulin resistance hair loss Around the abdomen around the waist Menstrual irregularities Hyperlipidemia (total cholesterol, HDL, LDL, triglyceride) Blood sugar BMI Weight Hirsutism score Hormone levels (free testosterone, FSH, LH, dehydroepiandrosterone sulfate, 17-hydroxy progesterone, TSH) blood pressure Complications

Simple randomization does not guarantee balance in the numbers in the study. In particular, if the patient's characteristics change over time (for example, patients are worse off early than after treatment), the imbalance cannot be corrected early. Block randomization is used to solve this problem. The main idea of ​​randomization of patients is to divide the block into M blocks of size 2N, so that in each block N patients are assigned A and patients N are assigned to B. The block is then randomly selected. This method ensures equal treatment allocation per block provided the block is fully utilized. For example: two treatments A, B and block size 2.2 = 4 Treatment allocation is possible within each block AABB (2) BBAA, (3) ABAB, (4) BABA, (5) ABBA, (6) BAAB The size of the block, depending on the number of treatments, should be short enough to prevent imbalance, and large enough to prevent guessing treatment allocation in each group during the study. The size of the block should be at least twice the number of treatment nodes. The size of the block is not stated in the study so that researchers are blind to it. If the blocks are expressed, the treatment series in each block can be guessed. For example, in block 2N = 4, A A B must be B and in A A as B B can be deduced. This can lead to (selection bias). The solution to prevent this error is to: (1) not reveal the block mechanism. (2). Use random block size.

Blinding: Patients are treated with medication packages pre-determined by the study supervisor (supervisor). Drug packages are completely similar in shape and the patient and the project manager are not aware of the contents of the packages. In addition, data collection, patient assessment and completion of forms is done by the project manager and his assistant who are not aware of the contents of the packages; In the data analysis stage, the analysis will be performed by the project consultant and the project manager who are not aware of the contents of the drug packages and only the group of patients (group 1 or 2) will be identified for data analysis; Therefore, the study is three-blind and from the stage of patient entry into the study to the study, data collection and analysis of information, the contents of the two drug groups are not known.

Will be published in the article

Will be published in the article

Everyone who reads the article

Will be published in the article

Will be published in the article

Will be published in the article