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IRCT20220130053874N1 IRCT 2022-10-19 Iran University of Medical Sciences Comparison of the effect of fenugreek (Moota) with metformin tablets in improving clinical symptoms and metabolic status of patients with polycystic ovary syndrome (PCOS) (PCOS) 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 2021-01-04 anticipated 110 Complete https://irct.ir/trial/62271 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 description: 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. 3 Polycystic ovary syndrome. Intervention 1: Intervention group: Patients receiving fenugreek medicine. Intervention 2: Control group: Patients receiving Metformin medicine. Yes - There is a plan to make this available What will be shared: Will be published in the article When: Will be published in the article To whom: Everyone who reads the article Conditions: Will be published in the article Where to obtain: Will be published in the article How to obtain: Will be published in the article Comments:
public Shahla Mir Galoo-Bayat
Shahid Hemmat Street
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8163 3102 mitrakazerooni.md@gmail.com Iran University of Medical Sciences scientific Shahla Mir Galoo-Bayat
Shahid Hemmat Street
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8163 3102 mitrakazerooni.md@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 1. Female infertility (ovarian factor) 2. Having two of the three criteria of polycystic ovary syndrome: oligomenorrhea or amenorrhea, clinical or biochemical symptoms of hyperandrogenism, polycystic ovaries in ultrasonographic view. 4. Fasting blood sugar (FBS) less than 200 mg / dL 5. Normal liver and kidney function (serum creatinine less than 1.4 mg / dL) 16 years 45 years Female History of medical conditions such as diffuse blood infection, renal failure, congestive heart failure, disorders of chemical characteristics of the kidney, gastrointestinal problems. Type 1 diabetes Adrenal disorders Hypothyroidism Use of other blood sugar medications E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: Patients receiving fenugreek medicine Control group: Patients receiving Metformin medicine Improve clinical symptoms. Timepoint: At the beginning of the intervention. Method of measurement: By checklist. Iran University of Medical Sciences Approved 2020-12-19 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)