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IRCT20200813048396N1 IRCT 2021-01-10 Shahed University Assessment of the efficacy of Saffron on happiness and quality of life in healthy adults Assessment of the efficacy of Saffron on happiness and quality of life in healthy adults 2021-01-19 anticipated 60 Complete https://irct.ir/trial/53148 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This study will take advantage of the random allocation method through the table of random numbers to develop subjects to the two intervention and placebo groups, Blinding description: Initially, 500 mg capsules of the drug containing 75 mg of saffron and 425 mg of bread powder are prepared and for the control group, using capsules similar to the main drug , with the same weight containing bread powder , which is similar to the intervention sample, is prepared . After preparation of drugs and placebos, the pharmacist researchers will assign a code to the medicine researchers will not know if each participant is in the medication group or the placebo group. 3 Healthy people. Intervention 1: Intervention group: Saffron in the form of 500 mg capsules containing 75 mg of saffron powder and 425 mg of bread powder, which is packed in 42 cans in the Clinical Research Center of Traditional Medicine of Shahed University. 28 capsules for 14 days, twice a day, one capsule each time and two hours after a meal. Saffron product is also determined based on the amount of crocin, determined and standardized. Intervention 2: Control group: The capsules are prepared in exactly the same way as bread powder and food coloring (500 mg) and are packed in 42 cans in the Clinical Research Center of Traditional Medicine of Shahed University. 28 capsules for 14 days, twice a day, one capsule each time and two hours after a meal. Yes - There is a plan to make this available What will be shared: All data can be shared after identifying individuals When: Access starts 6 months after the results are published To whom: Researchers in academic centers Conditions: After receiving the request, the amount of access will be announced Where to obtain: Dr Mohsen Naseri How to obtain: One month after receiving the written request, the result will be announced Comments:
public Mohsen Keyhan Soltani Hosseini
No.37 , Boostan 8th , Pasdaran Avenue
Tehran Iran (Islamic Republic of) 1666677311 +98 21 2258 9176 mksoltani47@yahoo.com Shahed University scientific Mohsen Naseri
Persian Golf freeway, in front of Holy Shrine
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5522 8800 naseri@shahed.ac.ir Shahed University Iran (Islamic Republic of) Indivisual's mental health ( indivisuals with scores lower than 7 in the depression section of GHQ mental health questionnaire , who will be referred to as "healthy indivisuals" in his study Obtaining informed consent 20 years 40 years Both History of mental disease according to GHQ mental health questionnaire Pregnancy or lactation Treatment - Drugs Placebo Intervention group: Saffron in the form of 500 mg capsules containing 75 mg of saffron powder and 425 mg of bread powder, which is packed in 42 cans in the Clinical Research Center of Traditional Medicine of Shahed University. 28 capsules for 14 days, twice a day, one capsule each time and two hours after a meal. Saffron product is also determined based on the amount of crocin, determined and standardized. Control group: The capsules are prepared in exactly the same way as bread powder and food coloring (500 mg) and are packed in 42 cans in the Clinical Research Center of Traditional Medicine of Shahed University. 28 capsules for 14 days, twice a day, one capsule each time and two hours after a meal. Change in happiness questionnaire score. Timepoint: Before intervention, Two weeks after starting the study. Method of measurement: Oxford questionnaire. Change in quality of life questionnaire score. Timepoint: Before intervention, Two weeks after starting the study. Method of measurement: SF-36 questionnaire. Shahed University Approved 2020-06-28 Shahed University Persian Gulf freeway, in front of the Holy Shrine Tehran Tehran Iran (Islamic Republic of)