The effect of chamomile on sleep in elderly

Phase 2

• Conditions: Insomnia.; Disorders of initiating and maintaining sleep [insomnias]

• Registration Number: IRCT2013102015080N1
• Lead Sponsor: Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran

Brief Summary

Background & Aim: Elderly people often suffer from sleep disorders. Chamomile due to the many health benefits such as sedation may be effective in improving sleep quality in elderly people. This study aimed to determine the effect of Matricaria chamomilla extract on sleep quality in elderly people admitted to nursing homes of Isfahan in 2014.<br /> Materials and Methods: The present study is a quasi-experimental clinical trial. The study population was 77 cases of elderly hospitalized in nursing homes. Participants were selected through random continuous sampling and divided into intervention and control groups. The intervention group received 400mg oral capsules of chamomile twice daily after lunch and after dinner for 4 weeks. The control group did not receive the intervention. Sleep quality in older adults before and after intervention, were compared using the Sleep Quality Questionnaire Index (PSQI). Data's were analyzed using descriptive statistics and paired t and independent t tests, one way ANOVA and Liner Regression Analysis, using SPSS software version 17.<br /> Results: Before intervention, the mean score of sleep quality both experimental and control groups showed no significant difference (P>0.05). After intervention, the mean score of sleep quality was a significant difference between experimental and control groups (P

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

tend to participate in the study and give consent to do so; having more than 60 years of age; having mental health; the non- occurrence of whatever specific diseases of liver, kidney, asthma, cancer and mental disorders are diagnosed; stay in one of the nursing homes studied; ability to answer questions; lack of sensitivity to chamomile or any of its ingredients; lack of continuous consumption of tea or chamomile extract during the last six months; capability than chamomile capsules orally; lack of sleep-related illnesses, such as obstructive sleep apnea or restless legs syndrome; the lack of dependence on any drug, analgesics, anti-depressants, sleeping, alcohol and the lack of heparin, warfarin, and aspirin ( due to drug interactions with chamomile extract ).
Exclusion criteria: stopping chamomile by subject, for whatever reason before the end of the intervention period; drug against the patient dose; catching whatever disease during the study period , which led to a ban by the oral administration of MC; indicate any allergic reaction to the MC during the research; lack of willingness to cooperate in the investigation; withdrawal from the study for reasons such as death, illness, or transferred to other centers.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of sleep. Timepoint: Pre-intervention and post-intervention. Method of measurement: Pittsburgh Sleep Quality Index.