Comparison of the effect of lavender and chamomile herbal tea on anxiety and depression in postmenopausal women referring to community health centers in Larestan in 1399
Design
The present study is a clinical trial study with a control group and two intervention groups that will be performed in parallel, without blinding, randomly on 96 postmenopausal women.
Settings and conduct
All postmenopausal women referring to community health centers in Larestan city
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age over 45 years
2. Do not use alternative therapies such as hormone therapy
3. Achieve mild to moderate depression score (score 14 to 28)
4. Having informed consent to participate in research
5. Ability to swallow and no oral and digestive problems that do not interfere with herbal tea.
6. Having the necessary vigilance to complete the questionnaires
7. Depression and anxiety disorders are not caused by physical problems such as hypothyroidism.
8. Candidates should not participate in other treatment programs that interfere with the present study.
9. Regular use of herbal tea according to the treatment plan
Exclusion criteria:
1- Unwillingness of samples to participate in research
2- History of allergy to herbal medicines
3- Addiction to drugs, alcohol and painkillers
4- Consumption of neuropsychiatric drugs
5- Having severe depression or anxiety
Intervention groups
The intervention includes the use of 2 grams of dried leaves of lavender and 2 grams of dried leaves of chamomile in each intervention group, which is boiled in 2 times in the morning and evening (Dried flowers of lavender and chamomile are placed in 300 ml of boiling water for 10-15 minutes) and consumed daily with the candy in the form of 2 cups of lavender tea and 2 cups of chamomile tea.
Main outcome variables
Beck Depression questionnaire and Spielberger Anxiety questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090304001742N6
Registration date:2020-08-19, 1399/05/29
Registration timing:prospective
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
mohammadrafi bazrafshan
Name of organization / entity
shiraz university medical science
Country
Iran (Islamic Republic of)
Phone
+98 917 382 1959
Email address
mrbazr@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lavender and chamomile herbal tea on anxiety and depression in postmenopausal women: A randomized clinical trial
Public title
Comparison of the effect of lavender and chamomile herbal tea on anxiety and depression in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 45 years
Do not use alternative therapies such as hormone therapy
Achieve mild to moderate depression score (score 14 to 28)
Having informed consent to participate in research
Ability to swallow and no oral or digestive problems that do not interfere with drinking.
Having the necessary vigilance to complete the questionnaires
Depression and anxiety disorder are not the result of physical problems such as hypothyroidism.
Candidates should not participate in other treatment programs that interfere with the present study.
Regular use of tea according to the treatment plan
Exclusion criteria:
Reluctance of samples to participate in research
History of allergy to herbal medicines
Addiction to drugs and alcohol and painkillers
Taking psychiatric drugs
Having severe depression or anxiety
Age
From 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
First, the list of community health centers in Larestan city that postmenopausal women refer to for health services is written on paper. In the next step, the name of each center is placed in a separate envelope and a simple envelope is selected at random. . Assisting the researcher to refer to the selected health center by using available sampling and applying the conditions for entering and leaving the study, sampling postmenopausal women. The selected samples are placed in each of the intervention groups or the control group according to the randomized blocks according to the inclusion in the study. Thus, according to the sample size of this study, which is estimated at 96 people, 8 blocks of 12 are used. This means that in each block, 4 people are in the intervention group of lavender tea, 4 people are in the chamomile tea intervention group and 4 people are in the control group. Sampling continues until 8 blocks are completed. Finally, 32 people in each group are selected in randomized blocks.
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
Ethics committee of Larestan University of Medical Sciences
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county, Fars province, Iran
City
Larestan
Province
Fars
Postal code
7431889629
Approval date
2020-06-30, 1399/04/10
Ethics committee reference number
IR.LARUMS.REC.1399.006
Health conditions studied
1
Description of health condition studied
Anxiety and depression in postmenopausal women
ICD-10 code
F32.0
ICD-10 code description
Depression
Primary outcomes
1
Description
Anxiety and depression
Timepoint
Before the intervention and immediately after the intervention
Intervention group:includes the use of 2 grams of dried leaves of lavender, which is boiled twice in the morning and evening (Dried lavender flowers are placed in 300 ml of boiling water for 10-15 minutes) and consumed daily with candy in the form of 2 cups of lavender herbal tea.
Category
Treatment - Drugs
2
Description
Intervention group: includes the use of 2 grams of dried leaves of Chamomile, which is boiled twice in the morning and evening (Dried Chamomile flowers are placed in 300 ml of boiling water for 10-15 minutes) and consumed daily with candy in the form of 2 cups of Chamomile herbal tea.
Category
Treatment - Drugs
3
Description
Control group: In this study, the control group did not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Larestan community health centers
Full name of responsible person
Dr. Mohammad-Rafi Bazrafshan
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
Larestan
Province
Fars
Postal code
7431895639
Phone
+98 71 5224 7110
Fax
+98 71 5224 7111
Email
m.bazrafshan@larums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Dr Mohammad Hossein Karimi
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Larestan University of Medical Sciences
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohammad-Rafi Bazrafshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sina Building (Larestan University of Medical Sciences), Behind Larestan Grand Bazaar, Karmandan St., North Ghadir Blvd., New City, Larestan county
City
Larestan
Province
Fars
Postal code
7431889629
Phone
+98 71 5225 5512
Email
m.bazrafshan@larums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Participants' information can be shared after it becomes unrecognizable
When the data will become available and for how long
Access begins a year after the publication of results
To whom data/document is available
People who are working in the academic and scientific institutions
Under which criteria data/document could be used
It needs the agreement of Larestan University of Medical Sciences
From where data/document is obtainable
Dr. Mohammad Rafi Bazrafshan, Associate Professor, Larestan School of Medical Sciences, Email: m.bazrafshan@larums.ac.ir, Contact Phone: 07152247110, Mobile Number: 09173821959
What processes are involved for a request to access data/document
Written and formal request to the vice chancellor for research of Larestan University of Medical Sciences