Sleep is one of the basic human needs. Research suggests that sleep quality is diminished with increasing age and the elderly are susceptible to damage caused by poor quality of sleep. Pharmacotherapy for the treatment of sleep disorders, which in many cases may cause adverse effects in the elderly. Research has shown that chamomile extract may be effective on sleep quality. Therefore, in this quasi-experimental clinical trial to determine the effect of MC extract on sleep quality in elderly people admitted to nursing homes takes place, aged 80, after informed consent, are divided into two groups. Intervention group twice daily after lunch and after dinner, chamomile extract 400 mg capsules and the control group received no intervention will be. Sleep quality in elderly people by participating in both pre- and post-intervention questionnaires Pittsburgh Sleep Quality Standard will be measured and will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102015080N1
Registration date:2014-05-23, 1393/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-23, 1393/03/02
Registrant information
Name
Mehrdad Abdullahzadeh
Name of organization / entity
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1275 5961
Email address
mehrdad11012@gmail.com
Recruitment status
Recruitment complete
Funding source
Khorasgan (Isfahan) Branch , Islamic Azad University
Expected recruitment start date
2014-05-14, 1393/02/24
Expected recruitment end date
2014-06-14, 1393/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Matricaria chamomilla extract on sleep quality in elderly people admitted to nursing homes of Isfahan in 2014
Public title
The effect of chamomile on sleep in elderly
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2014-05-14, 1393/02/24
Ethics committee reference number
23810403922004
Health conditions studied
1
Description of health condition studied
Insomnia
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
Quality of sleep
Timepoint
Pre-intervention and post-intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Chamomile extract of 400 mg twice daily
Category
Treatment - Drugs
2
Description
No action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nursing homes related to IsfahanWelfare
Full name of responsible person
Street address
City
Isfshsn
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
Full name of responsible person
Dr. payam najafi
Street address
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
Full name of responsible person
Mehrdad Abdullahzadeh
Position
Student
Other areas of specialty/work
Street address
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
City
Isfahan
Postal code
Phone
Fax
Email
mehrdad11012@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
Full name of responsible person
Dr. A. Naji
Position
PhD
Other areas of specialty/work
Street address
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
a-naji@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
Full name of responsible person
Mehrdad Abdollahzade
Position
Student
Other areas of specialty/work
Street address
Khorasgan (Isfahan) Branch , Islamic Azad University , Isfahan , Iran
City
Isfahan
Postal code
Phone
Fax
Email
mehrdad11012@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)