Determining the effect of borage tea on sleep disorders in postmenopausal women
Design
A two-group clinical trial with parallel groups is performed on 60 people. In both groups, the intervention is performed with borage tea or Wheat germ tea. Study is two-blinded. Sampling done with simple method and random allocation was done.
Settings and conduct
The ethical aspects were investigated and confirmed by the Research Ethics Committee of AJUMS, and the necessary permissions were obtained. Participants who had the inclusion criteria enrolled in this one-blinded study and randomization was conducted in A or B groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: amenorrhea for at least 12 months. 45-60 years old. Score more than 5 on the Pittsburgh Questionnaire
Exclusion criteria: Occurrence of any physical or psychological disorder during the study that causes sleep disorders. Discontinuation of borage tea consumption by the subject for any reason before the end of the intervention period. Having an underlying disease (hypertension - diabetes).
Use of hormone therapy. Having chronic disease (heart, renal, diabetes, hypertension). Consumption of alcohol and addictive substances. Having an allergy to borage tea. Taking benzodiazepines pills during the last 3 months.
Intervention groups
This study have 2 groups. Group A: receives borage tea. Group B: receives Wheat germ tea.
Main outcome variables
Sleep disorders in postmenopausal women.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200925048838N1
Registration date:2020-10-12, 1399/07/21
Registration timing:prospective
Last update:2020-10-12, 1399/07/21
Update count:0
Registration date
2020-10-12, 1399/07/21
Registrant information
Name
Leila Ghasemzadehdehkorde
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4372 2717
Email address
ghasemzadeh.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of borage tea on sleep disorders in postmenopausal women
Public title
The effect of borage tea on sleep disorders in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Amenorrhea for at least 12 years.
60-45 years old.
Score more than 5 on the Pittsburgh Questionnaire
Exclusion criteria:
Occurrence of any physical or psychological disorder during the study that causes sleep disorders.
Discontinuation of borage tea consumption by the subject for any reason before the end of the intervention period
Having an underlying disease ( hypertension - diabetes)
Use of hormone therapy.
Having Chronic disease (heart, kidney, diabetes, hypertension)
Consumption of alcohol and addictive substances.
Having an allergy to borage
Taking benzodiazepines pills during the last 3 months.
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using a random number table to create quadruple blocks in a one-to-one ratio that will be placed in two groups of 30 people to intervene and control.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, according to the apparent simulation in prescription tea and the use of a cup of the same size for similarity of the concentration of the substance in the two groups, the researcher and the participants do not know each person is in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Esfand Ave., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.AJUMS.REC.1399.156
Health conditions studied
1
Description of health condition studied
sleep disorders in postmenopausal women.
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Sleep disorder in postmenopausal women.
Timepoint
Pre-intervention, 8 weeks after the start of the intervention
Method of measurement
Variables are measured by demographic questionnaire, Pittsburg Sleep Quality Index (PSQL) and Insomnia Severity Index (ISI).
Secondary outcomes
1
Description
Sleep disorders in postmenopausal women.
Timepoint
Pre-intervention, 8 weeks after the start of the intervention.
Method of measurement
Variables are measured by demographic questionnaire, Pittsburg Sleep Quality Index (PSQL) and Insomnia Severity Index (ISI).
Intervention groups
1
Description
Intervention group: For this patient, if they have the inclusion criteria, after providing explanations about the dissertation plan and obtaining informed consent; before the intervention, the demographic information form, PSQL questionnaire and ISI questionnaire will be completed. 2-grams of borage tea is applied every night before going to bed for 8 weeks. a cup of the same size is purchased and given to all intervention groups to determine the same concentration. 8 weeks after the intervention, the questionnaires will be completed again by all subjects.
Category
Treatment - Other
2
Description
Control group: For this patient, if they have the inclusion criteria, after providing explanations about the dissertation plan and obtaining informed consent; before the intervention, the demographic information form, PSQL questionnaire and ISI questionnaire will be completed. In the control group, the intervention is applied by placebo. The placebo will also contain wheat germ powder in a 2-grams bag, which is quite similar in appearance to the bag containing 2-grams of borage tea and is given every night before bed for 8 weeks. Also, for all members of the group, a cup of the same size is purchased and given to determine the uniform concentration of the placebo. 8 weeks after the intervention, the questionnaires will be completed again by all subjects. It should be noted that the ineffectiveness of wheat germ on sleep disorders has been proven.