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IRCT20201022049117N1 IRCT 2020-12-02 Tarbiat Modares University Comparative assessment of the effect of complementary treatment with Cinnamon and Turmeric capsules on Polycystic Ovarian Syndrome: A triple blind clinical trial Comparative assessment of the effect of complementary treatment with Cinnamon and Turmeric capsules on Polycystic Ovarian Syndrome: A triple blind clinical trial 2020-11-30 anticipated 160 Complete https://irct.ir/trial/52175 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation of participants in study groups will be done by block-randomized randomization using Random allocation software, so that according to the groups under study (4 groups) 8 blocks of AABBCCDD will be formed and then all possible combinations of It will be listed and a code will be assigned to each of these combinations, then 20 blocks will be considered using a random number, depending on the sample size (160) and the volume of the blocks (8). The whole process will be performed under the supervision of an epidemiologist, Blinding description: This will be a triple-blind study, so that the participants, as well as researcher and analyzer of the results of the study will be unaware . For this purpose, the form of supplement capsules and placebo capsules are similar and the participants and the researcher are unaware of its content. In addition, the analyzer will not know which sample received which type of treatment. After completing the research and performing the relevant analyzes, the study groups will be asked and identified from the source of supply of drugs. 2 Polycystic Ovarian Syndrome. Intervention 1: Patients will be divided into four study groups (recipients of turmeric supplement capsules, cinnamon supplement, turmeric and cinnamon supplement, and control). A total of 160 samples will be randomly available from among women with PCOS. The capsules will be prepared in Urmia School of Pharmacy under the supervision of a respected pharmacist consultant and will contain 1000 mg of starch as a carrier. The capsules will not differ in weight, shape, color and smell, and they will be taken orally twice a day. The first intervention group will include turmeric (500 mg capsule) twice a day (morning and night). As drug therapy, medroxyprogesterone and metformin tablets will be prescribed to all patients undergoing concomitant supplements. How to prescribe medication under the supervision of a specialist doctor in the form of medroxyprogesterone tablets 5 mg once a day for ten days in the last ten days of the menstrual cycle, and metformin tablets 500 mg twice a day. The mentioned interventions will be performed for each of the subjects for three months (12 weeks). Follow-ups will be done by phone and weekly, as well as once a month in person and simultaneously through social networks. To assess patients' adherence to the treatment regimen, they will be asked to bring their medications with each visit and the number of unused capsules will be counted. While following up, the number of people who received the intervention and those who did not receive the intervention or received it irregularly will be determined by stating the reason, and those who did not receive the intervention or received it irregularly, They will be excluded from the study (failure to take the desired drugs for at least 7 days a month, according to studies, will lead to exclusion from the study), but will be included in the analysis with the intention of treatment. Intervention 2: Intervention group: Cinnamon (500 mg capsule) twice a day ( morning and night). Intervention 3: Intervention group: Combination of cinnamon and turmeric capsules 1000 mg twice a day (morning and night). Intervention 4: Control group: Placebo capsules twice a day (morning and night). 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 Data confidentiality
public Leili Rahmatnezhad
Jalal AleAhmad Nasr P.O.Box: 14115-111
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3590 leilirahmatnezhad@modares.ac.ir The University of Tarbiat Modares scientific Lida Moghaddam-banaem
Jalal AleAhmad Nasr P.O.Box: 14115-111
Tehran Iran (Islamic Republic of) 14115-111 +98 21 8288 3590 moghaddamb@modares.ac.ir The University of Tarbiat Modares Iran (Islamic Republic of) Age 18 to 45 years Diagnosis of PCOS by a gynecologist (according to clinical, laboratory, and imaging symptoms) Not pregnant now Failure to receive infertility treatment Do not take hormonal drugs or any medication for at least the last 3 months Do not take any medication or nutritional supplements More than 4 years after the onset of menarche Absence of severe underlying disease 18 years 45 years Female Do not take the desired drugs for at least 7 days a month The unwillingness of the participant to continue the participation for any reason Occurrence of any adverse or intolerable complications during the study due to the patient's complaint, or physician's diagnosis Occurrence of pregnancy E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Drugs Treatment - Drugs Treatment - Drugs Patients will be divided into four study groups (recipients of turmeric supplement capsules, cinnamon supplement, turmeric and cinnamon supplement, and control). A total of 160 samples will be randomly available from among women with PCOS. The capsules will be prepared in Urmia School of Pharmacy under the supervision of a respected pharmacist consultant and will contain 1000 mg of starch as a carrier. The capsules will not differ in weight, shape, color and smell, and they will be taken orally twice a day. The first intervention group will include turmeric (500 mg capsule) twice a day (morning and night). As drug therapy, medroxyprogesterone and metformin tablets will be prescribed to all patients undergoing concomitant supplements. How to prescribe medication under the supervision of a specialist doctor in the form of medroxyprogesterone tablets 5 mg once a day for ten days in the last ten days of the menstrual cycle, and metformin tablets 500 mg twice a day. The mentioned interventions will be performed for each of the subjects for three months (12 weeks). Follow-ups will be done by phone and weekly, as well as once a month in person and simultaneously through social networks. To assess patients' adherence to the treatment regimen, they will be asked to bring their medications with each visit and the number of unused capsules will be counted. While following up, the number of people who received the intervention and those who did not receive the intervention or received it irregularly will be determined by stating the reason, and those who did not receive the intervention or received it irregularly, They will be excluded from the study (failure to take the desired drugs for at least 7 days a month, according to studies, will lead to exclusion from the study), but will be included in the analysis with the intention of treatment. Intervention group: Cinnamon (500 mg capsule) twice a day ( morning and night) Intervention group: Combination of cinnamon and turmeric capsules 1000 mg twice a day (morning and night) Control group: Placebo capsules twice a day (morning and night) Irregular menstrual frequency. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations. Hirsutism. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations. Serum testosterone levels. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations. Serum FAI (Free Androgen Index). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations. Polycystic ovary. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: History, clinical and paraclinical examinations. HOMA-IR (Homeostasis Model Assessment - Insulin resistance ). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations. FBS (Fasting blood sugar). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations. (MDA) Malone di aldehyde. Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations. FSH ( Follicle-stimulating Hormone). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations. LH ( luteinizing hormone ). Timepoint: At the beginning of the study and after 12 weeks. Method of measurement: Paraclinical examinations. Tarbiat Modares University Approved 2020-10-27 Ethics committee of Tarbiat Modares University Tehran Jalal AleAhmad Nasr Tehran Tehran Iran (Islamic Republic of)