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IRCT20200404046942N1 IRCT 2020-04-29 Mashhad University of Medical Sciences Investigate the effect of Marrubium Vulgare dry powder of extract on Hormonal parameters and clinical finding in poly cystic ovarian syndrome Investigate the effect of Marrubium Vulgare dry powder of extract on Hormonal parameters and clinical finding in poly cystic ovarian syndrome 2020-05-21 anticipated 46 Complete https://irct.ir/trial/46919 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Other design features: The design of this study is N = 1, which means that a patient is given a treatment such as active therapy or placebo for a short time, Randomization description: The random assignment list will be created by computet(random number table using sites such as www.randomization.com or Excel software) and divided into two groups based on intervention and control. The method of the envelope is that the envelopes are prepared by a member of the research team and random numbers with the help of the site www.randomization.com and its printing is placed inside the envelope.the envelope door will be closed and its contents will not be visible from the outside,and then the petson will pick up an envelope and enter the control or intervention group based on its contents. The method of concealment of allocation is closed envelopes, Blinding description: The study is a three-way blind clinical trial in which the subjects,observers and analysts did not know any of the individuals in the study groups. 3 Polycystic Ovarian Syndrome. Intervention 1: Intervention group: The intervention group will receive 250 mg capsules of marrubium vulgare plant twice a day for two months.These capsules are made by Mashhad School of Pharmacy.In order to prepare the capsules, the extract from marrubium vulgare plant is converted into granules and then The capsules are filled with granules. Intervention 2: Control group: They will receive the placebo control group, which are similar capsules in terms of color with marrubium vulgare capsules and lack effective substance , with the same dose and method of use as the intervention group.The placebo will be provided by Mashhad School of Pharmacy. 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 Fatemeh Sargazi
4th floor, 14th unit,1th block, one saman residential complex, Shahrak Gharb, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3651 9853 sargazif931@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Sargazi
4th floor, 14th unit,1th block, one saman residential complex, Shahrak Gharb, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3651 9853 sargazif931@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Have a history of normal puberty Thyroid tests are normal Rotterdam criteria for polycystic ovarian syndrome The patients age is between 18 and 35 years Lack of thyroid disorders, Hyperprolactinemia, Hyper gonadotropic hypogonadism, Premature ovarian failure, Cushing´s syndroms, Congenital Adrenal Hyperplasia, Ovarian and Adrenal neoplasms and failure to develop physical illnesses Absence of pregnancy Lack of recent history of surgical treatment for Polycystic Ovarian Syndrome and treatment for Polycystic Ovarian Syndrome Do not use sex steroids(such as birth control pills, hormone therapy and androgenic drugs) and not use chemical and herbal medicines Do not use cigarettes and hookah 18 years 35 years Female Being pregnant use of sex steroids Suffering from thyroid disorders, hyperprolactinemia, hypergonadotropic hypogonadism, premature ovarian failure, Cushing's syndrome, congenital adrenal hyperplasia, ovarian and adrenal neoplasms, physical illness Having a history of recent treatment for polycystic ovary syndrome Being under 18 years of age or over 35 years of age E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Other Intervention group: The intervention group will receive 250 mg capsules of marrubium vulgare plant twice a day for two months.These capsules are made by Mashhad School of Pharmacy.In order to prepare the capsules, the extract from marrubium vulgare plant is converted into granules and then The capsules are filled with granules Control group: They will receive the placebo control group, which are similar capsules in terms of color with marrubium vulgare capsules and lack effective substance , with the same dose and method of use as the intervention group.The placebo will be provided by Mashhad School of Pharmacy In all patients, the level of testosterone is measured at the beginning of the visit and after the end of the treatment period. Timepoint: At the begining of the patient´s visit and after the end of the two-month treatment period. Method of measurement: Using blood samples and radioimmunoassay. In all patients, the level of estradiol is measured at the beginning of the visit and after the end of the treatment period. Timepoint: At the beginning of the visit and after the end of the two-month treatment period. Method of measurement: Using blood samples and radioimmunoassay. In all patients, the progesterone level is measured at the beginning and after the end of the treatment period. Timepoint: At the beginning of the visit and after the end of the two-month treatment period. Method of measurement: Using blood samples and radioimmunoassay. In all patients, the amount of cholesterol is measured at the beginning and after the end of the treatment period. Timepoint: At the beginning of the visit and after the end of the two-month treatment period. Method of measurement: Blood sample. In all patients, the amount of triglyceride is measured at the beginning of the visit and after the end of the treatment period. Timepoint: At the beginning of the visit and after the end of the two-month treatment period. Method of measurement: blood sample. In all patients, the amount of fasting blood sugar is measured at the beginning of the visit and after the end of the treatment period. Timepoint: At the beginning of the visit and after the end of the two-month treatment period. Method of measurement: blood sample. Changes in acne progression before and after treatment are evaluated. Timepoint: At the beginning of the patient´s visit and after the end of the two-month treatment period. Method of measurement: Assessment of hirsutism is performed using its own scurvy. Changes in menstrual irregularities are assessed. Timepoint: At the beginning of the visit and after the end of the two-month treatment period. Method of measurement: By calculating the menstrual cycle. Changes in body mass index before and after treatment are evaluated. Timepoint: At the beginning of the visit and after the end of the two-month treatment period. Method of measurement: Using the formula for calculating body mass index. Mashhad University of Medical Sciences Approved 2020-02-18 Ethics Committee of Mashhad university of medical sciences Deputy of Research and Technology, Qureshi Building, University street, Mashhad, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)