(1) Objectives: Evaluation of the effect of Matricaria Chamomile extract on sleep quality in elderly people, (2) Design: A single blind randomized controlled trial is conducting on sixty elderly adults with inclusion criteria. The subjects will randomly be allocated into two groups of 30, (3) Setting and conduct: Elderly adults with inclusion criteria who refer to the Kahrizak elderly day care charity will randomly allocated into the two groups. A permuted block randomization method is used to allocate the subjects into the two groups, (4) Participants: Elderly adults over the age of 60 years and with a score of 5 and over from the Pittsburgh Sleep Quality Index are recruited into the study, (5) Intervention: the elderly adults in the intervention group will receive two capsules containing 200 mg Matricaria Chamomile extract each day and for four weeks. The control group will receive two capsules containing wheat flour each day and for four weeks, (6) Main outcome measures: The quality of sleep of the subjects will be measured for three consecutive times with two-week intervals.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609023618N5
Registration date:2016-11-24, 1395/09/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-24, 1395/09/04
Registrant information
Name
Mohsen Adib-Hajbaghery
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36155540021
Email address
adibhajbagheri_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial for determining of the effect of Matricaria Chamomile extract on sleep quality in older adults
Public title
The effect of Matricaria Chamomile extract on sleep quality in older adults
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Age of 60 years and over; Obtaining a score of 5 or greater of the Pittsburgh Sleep Quality Index; Lack of a known mental illness; Lack of known allergies; Lack of continuous or sporadic use of Matricaria Chamomila or its products (as expressed by the patient); Being fully consciousness and ability to answer questions and give informed consent; Willingness to participate in the study and signing the informed consent; Not taking anticoagulant drugs (Heparin, Warfarin, Aspirin, Plavix); Lack of substance dependence and addiction (to drugs, alcohol, sedatives, antidepressants, hypnotics); Lack of known liver and kidney diseases or asthma, cancer, insulin-dependent diabetes, lupus, heart failure (based on the subjects’ health records).
Exclusion criteria: Intolerance or reactions to Chamomile while studying; Chamomile withdrawal before the end of the intervention (at least for 3 days); A patient’s decision to withdraw from the study; Death; Hospitalization; Transfer to other centers.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Ravand Street, Kashan
City
Kashan
Postal code
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
IR.KAUMS.REC.1394.157
Health conditions studied
1
Description of health condition studied
The effect of Matricaria Chamomile extract on sleep quality in older adults
ICD-10 code
G00-G99
ICD-10 code description
G99.8* Other specified disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Sleep quality
Timepoint
Pre the intervention, two weeks after the intervention, four weeks after the intervention, six weeks after the intervention
Method of measurement
The score resulted from the Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group: Capsules containing 200 mg of Matricaria Chamomile extract, are prescribed twice daily (after lunch and dinner) for four weeks.
Category
Treatment - Drugs
2
Description
In the control group: Capsules containing 200 mg wheat flour, are prescribed twice daily (after lunch and dinner) for four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Charity
Full name of responsible person
Mr Reza Roodgar
Street address
Saheb Al Zaman Stree, Mohammad Shahr, Alborz
City
Mohammad Shahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Science Kashan
Full name of responsible person
Doctor Ghulam Ali Hamidi
Street address
Ravand Street, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Science Kashan
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
Kashan University of Medical Sciences
Full name of responsible person
Seyedeh Nessa Moussavi
Position
Master of Science Student in Geriatric Nursing
Other areas of specialty/work
Street address
Laleh Alley, Golchin 2
City
Sari
Postal code
48137-44181
Phone
+98 11 3322 4854
Fax
Email
Yasamin.Rastgar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Adib-Hajbaghery
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Ravand Street, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
adib44@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyedeh Nessa Mousavi
Position
Master of Science Student in Geriatric Nursing
Other areas of specialty/work
Street address
Laleh Alley, Golchin 2
City
sari
Postal code
48137-44181
Phone
+98 11 3322 4854
Fax
Email
Yasamin.Rastgar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)