]>
IRCT20100713004364N2 IRCT 2023-09-11 Iran University of Medical Sciences Investigating the effect of Turmeric tablet on serum and follicular fluid inflammatory and oxidative stress indicators in women with polycystic ovary syndrome undergoing infertility treatment Investigating the effect of Turmeric tablet on serum and follicular fluid inflammatory and oxidative stress indicators in women with polycystic ovary syndrome undergoing infertility treatment 2023-06-23 anticipated 60 Complete https://irct.ir/trial/71768 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: A study is a three-blind randomized controlled trial in which the sampling will be continuous and the allocation of samples to the study groups will be random. Allocation of samples into two intervention and placebo groups will be done randomly and through the quadruple block method. The method of block classification is determined by someone other than the researcher using the seal envelope site, and the blocks are placed in opaque numbered envelopes, Blinding description: It is a three-blind randomization (researcher, people participating in the research, and a statistician). 3 Condition 1: Polycystic ovary syndrome. Condition 2: Women Infertility. Intervention 1: Intervention group: Turmeric tablet containing 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized by Dineh Pharmaceutical Company with drug registration number 7796008783541035, based on 5.47 mg of curcumin. 3 tablets are given daily to the internal group for 6 weeks. Intervention 2: Control group: Placebo tablets containing 500 mg of maltodextrin are used 3 times a day by Dineh Pharmaceutical Company for 6 weeks. 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 further information
public Leila Amini
Rashid Yasmi St. above Vanak Square, Vali Asr St. (AJ)
Tehran Iran (Islamic Republic of) 88201978 +98 21 8888 2886 amini.l@iums.ac.ir Iran University of Medical Sciences scientific Leila Amini
Rashid Yasmi St. above Vanak Square, Vali Asr St
Tehran Iran (Islamic Republic of) 88201978 +98 21 8888 2886 mahboubehkarimi78@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Women undergoing IVF infertility treatment Iranian origin Ages 18-40 years married Body mass branch below 30 kg/m2 18 years 40 years Female 1) Consumption of food and pharmaceutical supplements 2) Adhering to a special diet such as vegetarianism 3) Women with a history of infertility with simultaneous diagnosis of polycystic ovary syndrome and endometriosis 4) Hepatic and biliary disorders 5) under treatment with anticoagulant drugs 6) Active gastric ulcer 7) Having a history of allergy to turmeric or its products 8) Slimming diets 9) Athletes or special sports E28.2 N97 Polycystic ovarian syndrome Female infertility Prevention Placebo Intervention group: Turmeric tablet containing 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized by Dineh Pharmaceutical Company with drug registration number 7796008783541035, based on 5.47 mg of curcumin. 3 tablets are given daily to the internal group for 6 weeks. Control group: Placebo tablets containing 500 mg of maltodextrin are used 3 times a day by Dineh Pharmaceutical Company for 6 weeks. "Changes in inflammatory indices in women with polycystic ovary syndrome". Timepoint: 6 weeks after starting to take turmeric tablets. Method of measurement: Inflammatory indices in this study mean the measurement of C-reactive protein (in milligrams per liter), interleukin-6 (ELISA method) and the ratio of neutrophils to lymphocytes in the serum and follicular fluid of patients. IL-6: Interleukin 6 Human Platinum ELISA kit with ELISA method; It can be measured with a sensitivity of 0.92 pg/m and with a normal range of results: 1-100 pg/ml. CRP: Bionik CRP biochemistry kit made in Iran with photometric method and normal range of results: values up to 6 mg/L can be measured. Neutrophil to lymphocyte ratio: Sysmex model N-21KX machine is used for cell counting and to determine the percentage of neutrophils and lymphocytes, visual method or light microscope and Giemsa staining are used. And "Changes in oxidative stress indices in women with polycystic ovary syndrome". Timepoint: 6 weeks after starting to take turmeric tablets. Method of measurement: Oxidative stress indicators: Oxidative stress indicators in this research mean the measurement of malondialdehyde MDA (in micromolar per liter), total antioxidant capacity TAC and reactive oxygen radical ROS (milliunits per milliliter) in serum and follicular fluid of patients . MDA: It is measured using a 96-piece Well-plate kit made in Iran, Kia Biot Company, with a fluorimetric method that has a normal dynamic range: 20-100 µm. TAC: It is measured using a 96-piece Clean photometric plate well kit made in Iran, Kia Zeet company, with the Kuprak method, which has a dynamic range of 40-400 nmol/ml. ROS: It is measured by flow cytometry and fluorimetry using a kit of 96 Well Sterile Fluorimetric plates made in Iran, Kia Life Company. The fluorophore can be read at a wavelength of 525-485 Em/Ex=nm in plate fluorimetry or flow cytometry. Dineh Pharmaceutical Company of Iran Iran University of Medical Sciences Dineh Pharmaceutical Company of Iran Approved 2023-07-31 Ethics committee of Iran University of Medical Sciece Nursing & Midwifery faculty, Yasemi Ave, Valiasr St Tehran Tehran Iran (Islamic Republic of)