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IRCT20220330054370N1 IRCT 2022-04-07 Kashan University of Medical Sciences Effect of curcumin supplementation in elderly The effect of curcumin on mental health and sleep quality in elderly 2022-05-03 anticipated 70 Complete https://irct.ir/trial/62696 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of supplements. Supplements and placebos are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of intervention and after analyzing the data, packet codes are decoded. 3 Condition 1: Mental health. Condition 2: Quality of sleep. Intervention 1: Intervention group: In this group of patients (n=35) will be requested to take four curcuminoid capsules daily for 4 weeks (each capsules contain 40 mg curcumin). The curcuminoid capsules will be produced in the Nano Sina Elixir Company from curcuma. Intervention 2: Control group: In this group of patients (n=35) will be requested to take four placebo capsules daily for 4 weeks. The placebo capsules (Contain Starch) will be produced in the Nano Sina Elixir Company. 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) 8814187159 +98 31 5554 0021 afshar_m_1344@yahoo.com 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) 8814187159 +98 31 5554 0021 afshar_m_1344@yahoo.com 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 mental health questionnaire Score 3 and above on the sleep quality questionnaire Age of 60 to 70 years old 60 years 70 years Both History of allergy to curcumin plant products Complaints of known psychological illness and Alzheimer's Taking curcumin and antioxidant supplements during the last 3 months before the intervention Treatment - Drugs Placebo Intervention group: In this group of patients (n=35) will be requested to take four curcuminoid capsules daily for 4 weeks (each capsules contain 40 mg curcumin). The curcuminoid capsules will be produced in the Nano Sina Elixir Company from curcuma. Control group: In this group of patients (n=35) will be requested to take four placebo capsules daily for 4 weeks. The placebo capsules (Contain Starch) will be produced in the Nano Sina Elixir Company. Quality of sleep. Timepoint: At the beginning of the study, 4 and 8 weeks after intervention. Method of measurement: The Pittsburgh Sleep Quality Index. Mental health. Timepoint: At the beginning of the study, 4 and 8 weeks after intervention. Method of measurement: Goldberg Mental Health Questionnaire. Kashan University of Medical Sciences Approved 2022-03-06 Research Ethics Committees of Faculty of Medicine & Dentistry- Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)