]>
IRCT20200616047800N1 IRCT 2020-08-09 Kashan University of Medical Sciences The effect of crocin of saffron on sleep quality, general health and happiness in elderly population Clinical trial of the effect of crocin of saffron on sleep quality, general health and happiness in elderly population 2020-08-11 anticipated 70 Complete https://irct.ir/trial/49279 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The days of the week will be divided into two groups: even and odd, the elderly will be in one group on even days and the individual will be in another group on odd days, Blinding description: In this study, investigators, study participants, and Statistical Analyst will not know the type of supplement prescribed for the patient until the end of the data analysis. 3 Condition 1: Mental health. Condition 2: Happiness. Condition 3: Quality of sleep. Intervention 1: Intervention group: Crocin capsule, two oral 15 mg capsule, twice a day for 4 weeks. Intervention 2: Control group: placebo capsule, two oral 15 mg capsule, twice a day for 4 weeks. Yes - There is a plan to make this available What will be shared: At the end of the intervention, unidentified data will be disseminated. When: The data access period will start after the intervention. To whom: The data of this study will be made available to academic researchers and industry professionals. Conditions: Unidentifiable study data for use in industry and meta-analytical studies will be made available to academic researchers and industry professionals. Where to obtain: To access the study data, send a message to afshar_m_1344@yahoo.com or refer to Kashan University of Medical Sciences. How to obtain: After sending a written request to the main person in charge of this project (Dr Mohammad Afshar) and explaining the purpose of obtaining the study data, unidentifiable data will be provided to her. Comments:
public Mohammad Afshar
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
kashan Iran (Islamic Republic of) 87135/1416 +98 31 5554 0021 SADEGHI_H@SKUMS.AC.IR Kashan University of Medical Sciences scientific Mohammad Afshar
Kashan University of Medical Sciences, 5th kilometer of Qotb –e Ravandi Blvd, Kashan Kashan
kashan Iran (Islamic Republic of) 87135/1416 +98 31 5554 0021 SADEGHI_H@SKUMS.AC.IR Kashan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the intervention Ability to communicate verbally Get a score of 22 or higher on the general health questionnaire, score 5 and above on the sleep quality questionnaire and a score of 42 or less on the happiness questionnaire at the beginning of the study 60 years no limit Both History of allergy to saffron plant products Complaints of known psychological illness and Alzheimer's Taking crocin and antioxidant supplements during the last 3 months before the intervention Treatment - Drugs Treatment - Drugs Intervention group: Crocin capsule, two oral 15 mg capsule, twice a day for 4 weeks Control group: placebo capsule, two oral 15 mg capsule, twice a day for 4 weeks Quality of sleep. Timepoint: At the beginning of the study, 4 and 8 weeks after intervention. Method of measurement: The Pittsburgh Sleep Quality Index. General Health. Timepoint: At the beginning of the study, 4 and 8 weeks after intervention. Method of measurement: Goldberg General Health. Happiness. Timepoint: At the beginning of the study, 4 and 8 weeks after intervention. Method of measurement: Oxford Happiness. Kashan University of Medical Sciences Approved 2020-06-07 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)