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IRCT20240217061029N1 IRCT 2024-03-04 Mazandaran University of Medical Sciences Investigating the Effect of Celery Capsules on the Quality of Sleep and Quality of Life of the Elderly Investigating the Effectiveness of the Traditional Persian Medicine Product based on the Apium Graveolens on the Sleep Quality and Quality of Life of the Community-Dwelling Elderly 2024-04-03 anticipated 70 Complete https://irct.ir/trial/75723 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Supportive, Randomization description: The Random Block Method will be Used to Allocate the Samples to Two Groups. For this Purpose, Patients will Receive Numbers from 1 to 70 According to Their Arrival. The Randomization Unit will be Individually and by Number with Blocks of 4 Persons. The Selection of the Group Type for Each Person will be done Through the Random Allocation 2 Software. In Order to Create a Random Sequence, Codes A and B will be Generated from the Desired Software, where Code A Mean the Application of the Intervention Group and Code B Mean the Application of the Control Group for Each Person. Finally, the Codes will be Placed in the Sealed Envelope and the Number of Each Patient will be Written on the Envelope. As Each Patient Enters, the Doctor will Open the Envelope and Apply the Desired Treatment, Blinding description: Medicine and Placebo Capsules will be Prepared Similar to Each Other, Even in Color and Packaging Container, and Coded before the Intervention by a Statistician Colleague, so that the Researcher and the Participant will not Know the Type of Intervention. (It Should be Noted that at First, the Objectives of the Study are Explained to all Patients and Written Consent will be Obtained from the Patients). 3 Sleep Disorders in the Elderly. Intervention 1: Intervention Group: due to the Lack of a Similar Study to Investigate the Effectiveness of Celery Plant on Sleep Quality, in Order to Determine the Drug Dose, First 10 Patients (Elderly 60 Years and Older with Poor Sleep Quality) were Selected as a Pilot, of which 5 They Received one 500 mg Celery Capsule (each Capsule Contains 250 mg Dry Celery Extract and 250 mg Corn Starch) and 5 other People, Two 500 mg Celery Capsules (each Capsule Contains 250 mg Dry Celery Extract and 250 mg Starch. Corn), they will Receive it Orally One Hour before Going to Sleep, then by Checking the Quality of Sleep at the End of the Fourth Week, the Dose of the Drug will be Determined. Intervention 2: Control Group: After Determining the Drug Dose in the Intervention Group, the Control Group will also Receive the same Dose, 500 mg Capsules Containing Corn Starch, One Hour before Going to Bed at Night and will be Examined at the End of the Fourth Week. Yes - There is a plan to make this available What will be shared: Scores of Questionnaires When: 6 Months after the Results are Published To whom: Researchers Working in Academic and Scientific Institutions Conditions: Researchers Working in Academic and Scientific Institutions Where to obtain: hmtgh69@gmail.com hamta.ghasemi@mazums.ac.ir How to obtain: Email to the Researcher Comments:
public Hamta Ghasemi
2nd floor, Arshin Building 6, Haghighat Alley, Roudaki St., Amir Mazandarani Blvd
Sari Iran (Islamic Republic of) 4815699761 +98 11 3336 9274 hamta.ghasemi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Mohammad Yousofpoor
Mazandaran University of Medical Sciences Headquarters, the Beginning of Valiasr Highway, Joibar Junction, Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3304 4000 m.yousofpoor@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Desire to Participate in the Study and Give Informed Consent Age 60 Years and Older Low Quality of Sleep based on the Pittsburgh Sleep Quality Standard Questionnaire (Score 5 and above) Not Having Cognitive Impairment and Speech Impairment (Getting a Score of 25 or Higher on the MMSE Test) Not Having Diagnosed Mental Disorders that Interfere with Sleep, such as Restless Leg Syndrome, Obstructive Sleep Apnea, and Severe Depression and Anxiety Disorders, and are Treated with Relevant Drugs Not Having Dependence on any Narcotic Drugs, Sleeping Pills and Alcohol and Not Consuming These Items in the Last Month Not Having any History of Allergy to Celery and Similar Compounds Not Taking Drugs that Affect the Sleep-Wake Cycle and Anticoagulants Not Suffering from Physical Diseases that Affect the Sleep-Wake Cycle, such as Cancer, Liver and Kidney Disorders, Severe Anemia that Requires Treatment, and Coronary Heart Disorders. Not having Epilepsy, History of low Blood Pressure The Ability to Consume the Product Orally 60 years no limit Both Not Taking Medicine for 5 Consecutive Nights or 10 Alternating Nights Showing any Allergic Reaction to the Drug Reluctance to Cooperate Leaving the Study due to Reasons such as Death and Illness Unfortunate Events such as the Death of Relatives Treatment - Drugs Placebo Intervention Group: due to the Lack of a Similar Study to Investigate the Effectiveness of Celery Plant on Sleep Quality, in Order to Determine the Drug Dose, First 10 Patients (Elderly 60 Years and Older with Poor Sleep Quality) were Selected as a Pilot, of which 5 They Received one 500 mg Celery Capsule (each Capsule Contains 250 mg Dry Celery Extract and 250 mg Corn Starch) and 5 other People, Two 500 mg Celery Capsules (each Capsule Contains 250 mg Dry Celery Extract and 250 mg Starch. Corn), they will Receive it Orally One Hour before Going to Sleep, then by Checking the Quality of Sleep at the End of the Fourth Week, the Dose of the Drug will be Determined. Control Group: After Determining the Drug Dose in the Intervention Group, the Control Group will also Receive the same Dose, 500 mg Capsules Containing Corn Starch, One Hour before Going to Bed at Night and will be Examined at the End of the Fourth Week. The Sleep Quality Score of the Elderly based on the Pittsburgh Sleep Quality Standard Questionnaire. Timepoint: The Beginning of the Study (before the Start of the Intervention) and 4 Weeks after the Start of the Intervention. Method of measurement: Pittsburgh Sleep Quality Standard Questionnaire. The Score of the Quality of Life of the Elderly based on the Standard Questionnaire of the Quality of Life of the Elderly Lipad. Timepoint: The Beginning of the Study (before the Start of the Intervention) and 4 Weeks after the Start of the Intervention. Method of measurement: Standard Questionnaire of the Quality of Life of the Elderly Lipad. Mazandaran University of Medical Sciences Approved 2024-02-28 Research Ethics Committee of Mazandaran University of Medical Sciences 2nd Floor, Arshin Building 6, Haghighat Alley, Rudaki St.,Amir Mazandarani Blvd. Sari Mazandaran Iran (Islamic Republic of)