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IRCT20131009014957N6 IRCT 2019-02-01 Tabriz University of Medical Sciences The effect of oral capsule curcumin and vitamin E in comparison to placebo on serum levels of some antioxidants and inflammatory factors in postmenopausal women: A randomized, triple-controlled clinical trial. The effect of oral capsule curcumin and vitamin E in comparison to placebo on serum levels of some antioxidants and inflammatory factors in postmenopausal women: A randomized, triple-controlled clinical trial. 2019-02-09 anticipated 93 Complete https://irct.ir/trial/36909 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned randomly blocked blocks with 6 and 9 blocks and 1: 1: 1 assignment to three groups (two intervention groups and one control group) using RAS software, Blinding description: To hide the allocation, the same black, opaque, and back-numbered glasses (assignment sequences) inside them, either the curcumin capsule or the vitamin E capsule or the placebo capsule, will be used to hide the allocation. Preparation of glasses by an unoccupied person will be done in sampling and collecting data and analyzing them according to the assignment sequence. The first person will be in the condition of glass No. 1 and will continue until the sampling is completed. In all three groups, stratification based on BMI will be done alik. 3 Condition 1: TAC (Total Antioxidant Capacity). Condition 2: (Malondialdehyde) MDA. Condition 3: hsCRP (high sensitivity C-Reactive Protein). Condition 4: Early symptoms of manopause. Intervention 1: Intervention group: The first Intervention group will receive oral capsules of curcumin twice a day at a dose of 500 milligrams for eight weeks. Intervention 2: Intervention group:The second intervention group will receive oral Capsule Vitamin E 200 IU twice a day for eight weeks. Intervention 3: Control group: The control group will receive placebo capsules twice a day for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Dr. Azizeh Farshbaf Khalili
Faculty of Nursing Midwifery., South Shariati Street., Tabriz., Iran
Tabriz Iran (Islamic Republic of) 5155884818 +98 41 3479 6770 Farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr. Azizeh Farshbaf Khalili
faculty of Nursing Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 Farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 1) Readiness to participate in the study 2) Having sufficient literacy to complete the questionnaire or the presence of a literate person in the family 3) has normal menopause 4) Women who are less than 6 years old from their menopause. 5) having at least 40 years and a maximum of 60 6)Earn a minimum score of 15 and a maximum of 42 in the Green AssessmentHot flashes 40 years 60 years Female 1) Use of tobacco and alcohol and herbal medicines 2) Stress factors such as the death of first-degree relatives in the last 6 months and the loss of a job 3) Any acute and chronic inflammatory disease (including uncontrolled diabetes, rheumatoid arthritis) and infections in the body 4) The presence of malignant disease 5) History of recent surgery and trauma 6) History of allergy to turmeric or other drugs, food and color. 7) taking anticoagulants (heparin, varfarin, enoxaparin) 8) Take vitamin E supplementation, curcumin or estrogen therapy for 3 months prior to study 9) Use of special diets Treatment - Drugs Treatment - Drugs Placebo Intervention group: The first Intervention group will receive oral capsules of curcumin twice a day at a dose of 500 milligrams for eight weeks Intervention group:The second intervention group will receive oral Capsule Vitamin E 200 IU twice a day for eight weeks. Control group: The control group will receive placebo capsules twice a day for 8 weeks (Total Antioxidant Capacity) TAC. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: TAC levels will be measured with the Biorex kit. (Malondialdehyde) MDA. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Spectrophotometric and Atomic Absorption Comparison (AAS) will be measured. HsCRP (high sensitivity C-Reactive Protein). Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: A turbidometric method based on the formation of a complex resulting from the reaction between hs-CRP and its specific antiserum will be measured. Score of Menopause symptoms and its sub-scales. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Green Questionnaire. Food intake. Timepoint: Before the intervention, one month after the intervention and at the end of the intervention. Method of measurement: 24-hour Food record. Renal function tests. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods. Liver function tests. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods. ُSerum lipid profile. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods. Fasting blood sugar. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Using biochemical methods. Tabriz University of Medical Sciences Approved 2018-11-19 Ethics Committee of Tabriz University of Medical Sciences Research department., third floor., central construction number 2., Tabriz University of Medical Sciences., Golgasht Street., Azadi Avenue Tabriz East Azarbaijan Iran (Islamic Republic of)