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The effect of oral capsule of Ocimum basilicum leaf extract on sleep quality in menopausal women

Protocol summary

Study aim
Determination of the effect of oral capsule of ocimum basilicum leaf extract on sleep quality in postmenopausal women
Design
A randomized controlled clinical trial with 60 randomized, triple-blind, placebo-controlled trials on 60 postmenopausal women who were randomly assigned to each group using a random number table.
Settings and conduct
Mashhad Health Centers
Participants/Inclusion and exclusion criteria
Minimum literacy, post menopause, sleep quality scores above 5, 40 to 65 years, no history of sleep disorder requiring medical intervention (per person), no smoking and alcohol use, no smoking Hormone therapy for the past 6 months, no depression, stress or anxiety, no medical illnesses, no mental illnesses, no infectious and feverish illnesses, no simultaneous use of sleeping herbal remedies, Non-use of sleep-inducing chemical drugs, No use of anticoagulants, Anxiolytic drugs, No shift work the night
Intervention groups
Intervention group used oral capsule of ocimum basilicum leaf extract and control group received placebo containing starch.
Main outcome variables
Quality of sleep

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200104046001N1
Registration date: 2020-01-10, 1398/10/20
Registration timing: prospective

Last update: 2020-01-10, 1398/10/20
Update count: 0
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
fatemeh zahra karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1512
Email address
karimifz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral capsule of Ocimum basilicum leaf extract on sleep quality in menopausal women
Public title
Effect of Ocimum basilicum on sleep quality in menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least literacy Being a postmenopausal patient(Have at least 12 months spontaneous abstinence, with no association with pregnancy, lactation, or other medical, pharmaceutical, or serum FSH levels> 40IU / L.) Having a sleep quality score above 5 Age 40 to 65 years No history of sleep disorder requiring medical intervention (according to the person) Lack of allergy to Ocimum basilicum
Exclusion criteria:
Smoking and alcohol Hormone therapy in the past 6 months Having severe depression, stress, or severe anxiety(A score of less than 19 under the stress scale, a score of less than 10 under the anxiety scale, or a score of less than 14 under the DASS-21 Depression Scale) Medical illness(Such as, asthma, restless leg syndrome, kidney failure, liver disease,, chronic illness, seizure, Parkinson's disease, epilepsy, arthritis) Mental illness(Delirium, Schizophrenia, Alzheimer's) Infectious and feverish diseases(Respiratory tract infection, urinary and hepatitis, influenza, arthritis) Use herbal sleep medicines that affect sleep(Lavender, Spring Orange, Basil Lemon, herbal tea of Ocimum basilicum) Concomitant use of sleep-inducing chemical drugs(Clonidine, antidepressants, tamoxifen, raloxifene, anticonvulsants such as gabapentin, sedative) Use of anti-coagulants, anxiolytic drugs Having a night shift
Age
From 40 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Originally from Mashhad 5 and Samen districts, their names are written on paper. Two centers are selected by lot and each center has two centers that meet the conditions of staff cooperation and presence of postmenopausal women. After attending these centers, the menopausal women are selected after being given access to the research unit selection checklist, followed by oral capsules of basil leaf extract and placebo, administered by a pharmacy consultant professor at the Medicinal Plant Pharmacology Center of Mashhad University of Medical Sciences, Mashhad, Iran. The packaging is completely identical and only a drug consultant is aware of it will be provided with the researcher based on the code and Individuals with inclusion criteria who fall into groups according to the random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the basil leaf extract and placebo capsule to the researcher in similar forms and in identical cans, each researcher has a code that the pharmacy consulting professor is aware of. Individuals with inclusion criteria are randomly assigned to the groups using the random number table, so by the end of the study unit, the researcher and the statistical analyst will not know the codes for the basil leaf extract and placebo.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences-School of Nursing and Midwifery
Street address
School of Nursing and Midwifery,Doctora Crossroads,Daneshgah Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.070

Health conditions studied

1

Description of health condition studied
sleep disorder
ICD-10 code
G47
ICD-10 code description
Sleep disorders

Primary outcomes

1

Description
sleep quality
Timepoint
Before the study and immediately after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Oral Extract of Ocimum Basilicum Leaf Extract Made in the Pharmacology Department of Mashhad University of Medical Sciences, each capsule contains 500 mg of Basil Leaf Extract.research units consume one capsule daily before bedtime for one month
Category
Treatment - Other

2

Description
Control group: Control group: Use placebo with similar capsules and cans that Made in the Pharmacology Department of Mashhad University of Medical Sciences, each capsule contains 500 mg of Starch.research units consume one capsule daily before bedtime for one month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
samen health center
Full name of responsible person
محمدمهدی ایزدپناه
Street address
24,Akhund Khorasani,Gonbad sabz Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9135963114
Phone
+98 51 3852 6761
Email
hoseinih971@mums.ac.ir

2

Recruitment center
Name of recruitment center
shahid ghodsi health center
Full name of responsible person
Barat ali arab nejad
Street address
Next to Blood BankEnd of Sanabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3845 1552
Email
hoseinih971@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
DR. Bahreini
Street address
School of Nursing and Midwifery,Doctora Crossroads,Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hoseinih971@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
حمیده حسینی
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery ,Doktota Crossroads, ,DaneshgahStreet,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hoseinih971@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh zahra karimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,Doktora Crossroads, Daneshgah Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Karimifz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh hosseini
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,Doktora Crossroads, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
hoseinih971@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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