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The effect of Green tea tablet on the severity of Menopausal Symptoms in Postmenopausal women

Protocol summary

Study aim
The effect of Green tea tablet on severity of the menopausal symptoms of the menopausal women
Design
Clinical trial with control group, with parallel groups, triple blind, randomized
Settings and conduct
Participants in this study were randomly assigned to two groups of 45 individuals each: one group received green tea pills, while the other group received a placebo. The study will take place at comprehensive health service centers in Hamedan. To ensure unbiased results, neither the researcher, the postmenopausal women involved, nor the analyst will know the contents of the packages; this process is referred to as triple blinding. The intervention group will receive the green tea pills, while the control group will receive the placebo, both administered twice a day for a duration of 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 45-55, having menopause symptoms; not using cigarette or alcohol, not having physical or mental diseases, not using of relaxation techniques, not using of hormonal or herbal therapies Exclusion criteria: irregular use of the drug, refuse from continuing to participate in study
Intervention groups
Intervention group: The intervention group will take two 450 mg green tea tablets (produced by Dineh Company) daily, at least half an hour after each meal (breakfast and dinner), for six weeks. Control group: Participants will take two 450 mg placebo tablets daily for 6 weeks, similar to the intervention group.
Main outcome variables
Severity of menopause symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180707040370N12
Registration date: 2025-03-10, 1403/12/20
Registration timing: prospective

Last update: 2025-03-10, 1403/12/20
Update count: 0
Registration date
2025-03-10, 1403/12/20
Registrant information
Name
Ensiyeh Jenabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0496
Email address
e.jenabi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-10, 1404/02/20
Expected recruitment end date
2026-01-10, 1404/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Green tea tablet on the severity of Menopausal Symptoms in Postmenopausal women
Public title
The effect of Green tea tablet on the severity of Menopausal Symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 45-55 at least 1 to 5 years have passed since menopause Being married and leading a stable life with your spouse.
Exclusion criteria:
Acute and chronic illnesses observed during the study. Allergy to green tea supplements. Using cigarette or alcohol Taking any herbal or hormonal medications for three months before the intervention. Prior allergies to medical plants
Age
From 45 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly selected by random.org computer program that are assigned to the two groups of 45 recipients of Green tea tablet and placebo. The allocation of the participants to the groups is performed by method of allocation concealment. In this way, using the random block 4, the allocation sequence is specified. Then, in the sealed envelopes, the intervention name is written in sequential order, and is numbered accordingly
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug packages are similar and were given to menopausal women by other person. This person does not inform about the package contents. Therefore, neither the researcher, nor the menopausal women and nor the analyzer knows the contents of the package and triple blinding will be performed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmiheh Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2025-03-01, 1403/12/11
Ethics committee reference number
IR.UMSHA.REC.1403.878

Health conditions studied

1

Description of health condition studied
Severity of the Menopausal Symptoms
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
Severity of menopause symptoms
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
MRS scale

Secondary outcomes

1

Description
Stress
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Questionnaire DASS-21

2

Description
anxiety
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Questionnaire DASS-21

3

Description
depression
Timepoint
Before the intervention, 3 and 6 weeks after the intervention
Method of measurement
Questionnaire DASS-21

Intervention groups

1

Description
Intervention group: The intervention group will take two 450 mg green tea tablets (produced by Dineh Company) daily, at least half an hour after each meal (breakfast and dinner), for six weeks.
Category
Treatment - Drugs

2

Description
Control group: Participants will take two 450 mg placebo tablets daily for 6 weeks, similar to the intervention group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Service Center of Shohada
Full name of responsible person
Ensiyeh Jenabi
Street address
Comprehensive Health Service Center of Shohada., Takhti Ave., Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838344
Phone
+98 81 3252 4321
Email
Shohada.health@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza soltanian
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Av
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
arsoltanian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ensiyeh Jenabi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0496
Email
en.jenabi@yahoo.com

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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Data analysis is permitted with the author's permission.
From where data/document is obtainable
Hamadan ،Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Responsible person: Ensiyeh Jenabi Postal code: 6517838695 Phone number: +98 81 3838 0496 Email: en.jenabi@yahoo.com
What processes are involved for a request to access data/document
Requests should be submitted to the corresponding author via email. He will follow up with the inquiry
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