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IRCT20210403050818N1 IRCT 2021-04-09 Larestan University of Medical Sciences The effect of Crocus sativus (saffron) herbal tea on happiness The effect of Crocus sativus (saffron) herbal tea on happiness in postmenopausal women: A randomized clinical trial 2021-05-22 anticipated 72 Complete https://irct.ir/trial/55304 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized block methods are used to randomly assign participants to intervention and control groups. The selected samples are placed in each of the intervention groups or the control group according to the randomized blocks according to the inclusion in the study. Thus, according to the sample size of this study, which is estimated at 72 people, 9 blocks of 8 are used. Each block consists of cells A and B. According to the previous agreement, cell A will belong to the intervention group and cell B will belong to the control group. At this stage, the researcher who assigns individuals to the intervention and control group will not know the type of allocation. This means that in each block, 4 people are in the intervention group and 4 people are in the control group. Sampling continues until 9 blocks are completed. Finally, 36 people in each group are selected in randomized blocks. N/A Happiness score in postmenopausal women. Intervention 1: Intervention group: The intervention will involve the use of 30 mg of dried stigmas of the saffron plant, which are boiled once in the morning (in 300 ml of boiling water for 10-15 minutes).And with candy, it will be consumed daily in the form of 1 cup of saffron herbal tea. Patients will be instructed to use the drug completely and at the same time avoid using other herbs. According to previous research, the duration of this intervention will be 2 weeks. According to the results of previous studies, the maximum safe daily dose of saffron is 1.5 grams, so it is expected that the dose in the present study does not cause side effects. The subjects of the intervention group will receive the number of their drinks (30 mg teabags) for the whole study period (2 weeks) as soon as they enter the study, to monitor the consumption of saffron in the intervention group, according to the previous agreement and maintaining the confidentiality of information. The group will be contacted daily (up to two weeks) and the process of saffron consumption will be evaluated. Intervention 2: Control group: A glass of hot water and candy is provided daily for the control group. 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 Confidentiality of personal information
public Hamed Delam
North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar
Larestan Iran (Islamic Republic of) 7431889629 +98 71 5225 5512 h.delam@larums.ac.ir Larestan University of Medical Sciences scientific Hamed Delam
Shahr-e Jadid - North Ghadir Boulevard, Karmandan Street - behind Larestan Grand Bazaar, Fars, Larestan, Iran
Larestan Iran (Islamic Republic of) 7431889629 +98 71 5224 7110 h.delam@larums.ac.ir Larestan University of Medical Sciences Iran (Islamic Republic of) Samples are willing to participate in research voluntarily. Volunteers do not suffer from acute psychosis, chronic and debilitating diseases and cognitive diseases such as dementia and They have also not been treated similarly recently. Candidates should be familiar with Persian language. Candidates should not participate in other treatment programs that interfere with the present study. Candidates should be able to swallow and have no oral or digestive problems that interfere with drinking. 47 years no limit Female Occurrence of any social, family crisis during the study Hospitalization or acute and chronic illness that interferes with research. History of allergy to herbal medicines Reluctance of the samples to continue participating in the research Addiction to drugs and alcohol and painkillers Taking psychiatric drugs F32.8 Other depressive episodes Treatment - Drugs N/A Intervention group: The intervention will involve the use of 30 mg of dried stigmas of the saffron plant, which are boiled once in the morning (in 300 ml of boiling water for 10-15 minutes).And with candy, it will be consumed daily in the form of 1 cup of saffron herbal tea. Patients will be instructed to use the drug completely and at the same time avoid using other herbs. According to previous research, the duration of this intervention will be 2 weeks. According to the results of previous studies, the maximum safe daily dose of saffron is 1.5 grams, so it is expected that the dose in the present study does not cause side effects. The subjects of the intervention group will receive the number of their drinks (30 mg teabags) for the whole study period (2 weeks) as soon as they enter the study, to monitor the consumption of saffron in the intervention group, according to the previous agreement and maintaining the confidentiality of information. The group will be contacted daily (up to two weeks) and the process of saffron consumption will be evaluated. Control group: A glass of hot water and candy is provided daily for the control group. Happiness. Timepoint: Measurement of happiness score before intervention and 2 weeks after intervention. Method of measurement: Oxford Happiness Questionnaire. Larestan University of Medical Sciences Approved 2021-03-01 Ethics Committee of Larestan University of Medical Sciences North Ghadir Boulevard, Karmandan Street, behind Larestan Grand Bazaar Larestan Fars Iran (Islamic Republic of)