The determine of the effect of chamomile tea on anxiety and depression in postmenopausal women.
Design
A two-group clinical trial with parallel groups is performed on 68 people. In both groups, the intervention is performed with chamomile tea or placebo. Study is one-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: Interested in participating in the study. Having at least elementary education. 45-60 years old. Amenorrhea for at least 1 year. Mild to moderate anxiety and depression symptoms (according to DASS scale).
Exclusion criteria: Having allergy to chamomile. Major depression that need to special treatment. Person who have suicidal thoughts and self-harm. Having renal, liver, cardiac and thyroid disease, bleeding disorder and malignancies. degenerative, auto immune and psychological disorders. Using of anti-depression and sedative drugs in 3 months ago. Having a history of stressful events or tragic events in recent months such as the death of a spouse or close persons. Having a history of drug or alcohol abuse.
Intervention groups
This study have 2 groups.
Group A: receives chamomile.
Group B: receives placebo.
Main outcome variables
Anxiety and depression in postmenopausal women.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200818048452N1
Registration date:2020-11-05, 1399/08/15
Registration timing:registered_while_recruiting
Last update:2020-11-05, 1399/08/15
Update count:0
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
Zohreh Zamanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3621 0123
Email address
zohrehzamanpour1400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of chamomile tea on anxiety and depression in postmenopausal women
Public title
The effect of chamomile tea on anxiety and depression in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in the study.
Having at least elementary education.
45-60 years old.
Amenorrhea for 1 year.
Mild to moderate anxiety and depression symptoms (according DASS scale).
Exclusion criteria:
Having allergy to chamomile.
Major depression that need to special treatment.
Person who have suicidal thoughts and self-harm.
Having renal, liver, cardiac and thyroid disease, Bleeding disorder and malignancies, degenerative, auto immune and psychological disorder.
Using of anti-depression and sedative drugs in 3 months ago.
Having a history of stressful events or tragic events in recent months such as the death of a spouse or close persons.
Having a history of drug abuser or alcohol abuse.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
68
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)
Single blinded
Blinding description
In this study, participants did not know each person was placed in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی اهواز
Street address
Esfand Ave., Golestan Blvd.,
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.AJUMS.REC.1399.228
Health conditions studied
1
Description of health condition studied
Anxiety and depression in postmenopausal women.
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety and depression in postmenopausal women.
Timepoint
Pre-intervention, 4 weeks after the start of the intervention, 8 weeks after the start of the intervention.
Method of measurement
Variables are measured by demographic questionnaire and DAAS-21 scale.
Secondary outcomes
1
Description
Anxiety and depression in postmenopausal women.
Timepoint
Pre-intervention, 4 weeks after the start of the intervention, 8 weeks after the start of the intervention.
Method of measurement
Variables are measured by demographic questionnaire and DAAS-21 scale.
Intervention groups
1
Description
Intervention group: For this patient if they had the inclusion criteria, after submitting a description and obtaining informed consent, The DAAS-21 questionnaire and the demographic information form will be completed pre-intervention. Each patient consumes three sachets daily at least half an hour after each meal. In this way, 2.5 grams of dried German chamomile flowers made by Golestan factory are placed in 150 cc of boiling water every time. The duration of putting the tea in boiling water is the same for all people. Patients are followed up 4 weeks after the intervention and 8 weeks after the intervention and the DAAS-21 questionnaire is completed for them.
Category
Treatment - Other
2
Description
Control group: For this patient if they had the inclusion criteria, after submitting a description and obtaining informed consent, The DAAS-21 questionnaire and the demographic information form will be completed pre-intervention. In this group, the intervention is applied with the placebo that contains wheat germ powder. Each patient consumes three bags of placebo daily for at least half an hour after each meal. Each time, 2.5 grams of placebo, which is similar in shape and size to the chamomile tea bag made by Golestan factory, is placed in 150 cc of boiling water. The duration of putting the bag in the boiling water is the same for all participants. Patients are followed up 4 weeks after the intervention and 8 weeks after the intervention and the DAAS-21 questionnaire is completed for them. It should be noted that placebo contains wheat germ powder, which according to scientific articles and documents has no therapeutic effect on anxiety and depression.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Health Center No. 10
Full name of responsible person
Zohre Zamanpoor
Street address
Golestan Ave., Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
61936 73111
Phone
+98 61 3332 8375
Email
zohrehzamanpour1400@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspour
Street address
Golestan Blvd., Esfand Ave.
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3336 7543
Email
abbaspoor_z762@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Zohreh Zamanpour
Position
Master of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.79, West Azadeh 2 Ave., Moalem Blvd., Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3621 0123
Fax
Email
zohrehzamanpour1400@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd., Esfand Ave
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 7543
Email
abbaspoor_z762@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zohreh Zamanpour
Position
Master of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.79, West Azadeh 2 Ave., Moalem Blvd., Ahwaz Town
City
Ahwaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3621 0123
Fax
Email
zohrehzamanpour1400@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
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