Investigating the Effect of Celery Capsules on the Quality of Sleep and Quality of Life of the Elderly

Phase 3

Conditions: Sleep Disorders in the Elderly.

Registration Number: IRCT20240217061029N1

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.