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IRCT20230222057493N1 IRCT 2023-03-28 Arak University of Medical Sciences The effect of Vitex agnus_castus plant in women with polycystic ovary syndrome The effect of Vitex agnus_castus plant on some marker of oxidative stress, lipid profile and insulin resistance in women with polycystic ovary syndrome: A randomized double blind clinical trial study 2023-04-03 anticipated 60 Complete https://irct.ir/trial/68740 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation method will be used and the patients are placed in the intervention or control group using the block random allocation method with blocks of four. By assigning the letter A to the intervention group and the letter B to the control group, six states AABB, BBAA, BABA, ABBA, BAAB, and ABAB are written on separate sheets and are thrown into a container, and each time one of the sheets is taken out and it's written composition is noted and the sheet is thrown into the container again. Since the sample size in this study is 60, this procedure is repeated 15 times and each time the combination written on each sheet is noted in the sequence of the previous sheet. Then, a number from one to sixty is assigned to each of the letters in the order of the letters noted one after the other, and each of the letters are placed in an envelope and the specific number of each letter is written on the envelope. Every time which a subject is selected, one of the envelopes is opened. According to the number written on the envelope, the patient is introduced into the intervention or control group, Blinding description: Participants and healthcare providers are blinded. The drug and placebo are packaged in similar packages. The treatment group and placebo group will not be aware of the type of intervention they receive. 2-3 Polycystic ovary syndrome. Intervention 1: Intervention group: Agnugol tablet (a coated tablet containing the dry extract of the Vitex agnus_castus plant in the amount of 2.3-8.4 mg and an average of 5.35 mg, standardized to 0.42-0.82 mg Aucubin) once a day for 12 weeks(Gol Daro Pharmaceutical Company-Iran-Isfahan Province). Intervention 2: Control group: placebo tablet similar to Agnugol,1 pill per day for 12 weeks. Yes - There is a plan to make this available What will be shared: Only results of main outcomes When: Six months after publishing of the results To whom: Only for academic staffs and universities researches Conditions: Only for international and between universities researches Where to obtain: Farideh Jalali-Mashayekhi mashayekhif@yahoo.com How to obtain: 1. Requesting a team work clinical trial via email. 2. Approving the proposal. 3. Registration of the trial Comments: No comments
public Aniseh Hatami
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3645 Aniseh.hatami@yahoo.com Arak University of Medical Sciences scientific Aniseh Hatami
Department of Biochemistry, School of Medicine, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3501 Aniseh.hatami@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Women in the age range of 18-45 years Confirmation of PCOS by a specialist doctor, based on Rotterdam criteria Patient satisfaction to enter the study Patients who do not intend to become pregnant because the profile of therapeutic drugs for people who intend to become pregnant is different from those who do not intend to become pregnant 18 years 45 years Female Smoking Thyroid disorders Hyperprolactinemia Diabetes Pregnancy Consumption of dopamine antagonists Consumption of antioxidant supplements Breastfeeding E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: Agnugol tablet (a coated tablet containing the dry extract of the Vitex agnus_castus plant in the amount of 2.3-8.4 mg and an average of 5.35 mg, standardized to 0.42-0.82 mg Aucubin) once a day for 12 weeks(Gol Daro Pharmaceutical Company-Iran-Isfahan Province). Control group: placebo tablet similar to Agnugol,1 pill per day for 12 weeks Total antioxidant capacity. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Total oxidant status. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Oxidative stress index. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Formula. Malondialdehyde. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. High density lipoprotein (HDL-C). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Spectrophotometry. Low-density lipoprotein(LDL-C). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Triglyceride. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Fasting glucose. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Catalase. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Insulin resistance. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: HOMA-IR model evaluation. Reduced Glutathione. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Glutathione peroxidase. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Total Thiol. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Aspartate aminotransferase(AST). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Alanine aminotransferase(ALT). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Number of periods. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: To ask the patient and dividing the total number of menstruations that occurred in three months by the expected number of menstruations (three times in three months). The rate of hirsutism. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Ferriman_gallway score. Insulin. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: ELISA. Cholesterol. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric. Ovary volume. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Ultrasonography. Tumor necrosis factor alpha (measuring on 40 patients). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: ELISA. Interleukin-6 (measuring on 40 patients). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: ELISA. Anti-Mullein Hormone (measuring on 40 patients). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: ELISA. C-reactive protein. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: ELISA. The ratio of C-reactive protein to albumin. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Formula (C-reactive protein / albumin). The ratio of blood urea nitrogen to albumin. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Formula (blood urea nitrogen / albumin). Albumin bilirubin score. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Formula (Albumin × -0.085) + (log10 Bilirubin × 0.66). Triglyceride-Glucose index. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Formula (Fasting triacylglycerols × Fasting glucose/2). Body mass index (BMI). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Weight /( height)^2. Arak University of Medical Sciences Approved 2023-02-12 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of) Approved 2024-05-19 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of) Approved 2024-10-06 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)