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IRCT20211017052785N2 IRCT 2022-06-14 Karaj University of Medical Sciences The effect of herbal medicine (Tiryaqe wabai) on anxiety, depression and sleep in the elderly The effect of herbal medicine (Tiryaqe wabai) on anxiety, depression and sleep in the elderly: A double-blind randomized controlled clinical trial 2022-08-06 anticipated 108 Complete https://irct.ir/trial/63809 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of individuals to the intervention and control groups will be done using block randomization method with the size of 4, 6 and 8 non-identical blocks (to hide the allocation). Statistical or web-based software such as https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for this purpose. In this method, the order of block size as well as the allocation of people in groups is randomly selected. In such a way that first 4, 6 or 8 blocks are randomly selected and in the selected block, the order of assigning individuals to the intervention and control group is determined randomly. In the study, they will be assigned to the intervention and control groups based on the production chain, respectively, Blinding description: For blinding, medicine and placebo are prepared, packaged and numbered by the pharmacist and the project manager and sampler will not be informed of their contents. Patients are also unaware that the capsule is taking medication or placebo. 3 Condition 1: Depression. Condition 2: anxiety disorder. Intervention 1: Intervention group: Intervention group: One capsule of Tiryaqe wabai is taken daily for 30 days one hour before dinner. Raw materials of medicine, prepared from reliable sources. And an initial assessment is made of its quality. Tiryaqe wabai is prepared by mixing Saffron powders, Aloe vera gel and Myhrr and according to the instructions mentioned in the sources of traditional medicine, including the Tohfat al mo'menin, the Exire A'zam, and Tebe Akbari, and is packaged in the form of capsules. Standardization of the drug is done by measuring total phenol, determining the amount of crocin and alloine, as well as microbial control. Intervention 2: Control group: Take one placebo capsule daily for 30 days one hour before dinner. A suitable placebo is prepared with sufficient similarity and is prepared in similar packages of the drug. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main consequences, can be shared by inserting it in the study article. When: Access period starts 8 months after the results are published To whom: Only for researchers working in academic and scientific institutions Conditions: Using data to advance scientific goals Where to obtain: Dr. Maarefvand How to obtain: Send the request for information via the announced gmail and the party will receive a response within a maximum of two weeks. dr.m.maarefvand@gmail.com Comments:
public Mina Maarefvand
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3774 dr.m.maarefvand@gmail.com Karaj University of Medical Sciences scientific Mina Maarefvand
45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3774 dr.m.maarefvand@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) Men and women aged 60 to 75 years referred to the health center of Karaj city Having the desire and satisfaction to participate in the project Obtain more than a quarter of the score from each of the three Depression, Sleep, and Anxiety Questionnaires 60 years 75 years Both Inability to take the drug in capsule form Do not have a history of allergies to any of the ingredients used in the medicine Do not change the amount of medication taken for any of the three conditions of anxiety, depression and sleep Have serious underlying conditions such as uncontrolled blood pressure or diabetes, untreated ischemic heart disease, kidney and liver failure. F34 F41.1 Persistent mood [affective] disorders Generalized anxiety disorder Treatment - Drugs Placebo Intervention group: Intervention group: One capsule of Tiryaqe wabai is taken daily for 30 days one hour before dinner. Raw materials of medicine, prepared from reliable sources. And an initial assessment is made of its quality. Tiryaqe wabai is prepared by mixing Saffron powders, Aloe vera gel and Myhrr and according to the instructions mentioned in the sources of traditional medicine, including the Tohfat al mo'menin, the Exire A'zam, and Tebe Akbari, and is packaged in the form of capsules. Standardization of the drug is done by measuring total phenol, determining the amount of crocin and alloine, as well as microbial control. Control group: Take one placebo capsule daily for 30 days one hour before dinner. A suitable placebo is prepared with sufficient similarity and is prepared in similar packages of the drug. Anxiety Severity. Timepoint: Beginning and end of the study. Method of measurement: Hamilton Anxiety Questionnaire. Depression severity. Timepoint: Beginning and end of the study. Method of measurement: Beck Depression Inventory BDI-II. Sleep status. Timepoint: Beginning and end of the study. Method of measurement: Petersburg Sleep Quality Questionnaire (PSQI). Karaj University of Medical Sciences Approved 2022-05-21 Ethics Committee of Alborz University of Medical Sciences 45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology Alborz Alborz Iran (Islamic Republic of)