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The effect of Achillea officinalis extract on premenstrual syndrome in female students living in dormitory of Qazvin University of Medical Sciences

Protocol summary

Summary
The study titled "The Effect of Yarrow's Extract on Premenstrual Syndrome in Female Female Students in Dormitory of Qazvin University of Medical Sciences" will be conducted as a randomized clinical trial on female students residing in the dormitory of Qazvin University of Medical Sciences in 1395. In this research, all female students living in dormitories of Qazvin University of Medical Sciences as a research community. Girls living in dormitories of Qazvin University of Medical Sciences, who have moderate and severe forms of premenstrual syndrome and who have the conditions for entering the study, will be included in the study if they are willing to participate in the study. In the case of people who meet the conditions for entry into the study, the Temporary Pre-menstrual Diagnosis (PMS) form will be provided and collected. Depression tests will be provided to them at least 5 signs of the symptoms. If the subjects are natural and non-depressed on the basis of the score, they will be selected as the research unit and written consent will be obtained for participation in the study. Then, the form for registering the daily symptoms of the symptoms will be completed for two consecutive cycles by the samples. In case of self-treatment, the sample will be excluded from the study. The data gathering tool in this study was a modified PSN screening screening questionnaire, which shows the severity of the disease as necessary and effective in the life of individuals, and is more practical and time-consuming from a two-cyclical chart. To be more economical. This questionnaire consists of two parts of the symptoms and the effects of symptoms on individuals' lives. (31) Companies will be randomly divided into two groups. To the intervention group, an average glass of Yarrow's extract containing 300 μg of effective ingredient in Qazvin Pharmaceutical Company (Qazvin) will be given three times daily for seven days late in the luteal phase. The control group will receive their routine treatment. Physical and psychological symptoms will be measured separately before intervention, one month after intervention, two months after the intervention and three months after the intervention. Samples will be required to report any side effects.

General information

Acronym
Effect of Achillea officinalis extract on premenstrual syndrome
IRCT registration information
IRCT registration number: IRCT2017010831829N1
Registration date: 2017-10-29, 1396/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-29, 1396/08/07
Registrant information
Name
Mehri Kalhor
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3223 2149
Email address
mehrikalhor@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research in Nursing and Midwifery Faculty of Qazvin University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Achillea officinalis extract on premenstrual syndrome in female students living in dormitory of Qazvin University of Medical Sciences
Public title
The effect of Achillea officinalis extract on premenstrual syndrome in female students living in dormitory of Qazvin University of Medical Sciences
Purpose
Treatment
Inclusion/Exclusion criteria
The criteria for entering the study include regular menstruation with intervals of 24-35 days; a natural body mass index of 19.86 - 26.6; no physical or mental illness or drug use; non-use of hormonal drugs and prevention of hormonal contractions and vitamins and anti seizures and antidepressants in the last 3 months; having symptoms in the second half of the cycle; having symptoms in three consecutive cycles and not smoking.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 360
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Ghazvin University of Medical Sciences, Nawab St.
City
Qazvin
Postal code
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
IR.QUMS.REC.1394.349

Health conditions studied

1

Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Premenstrual Syndrome
Timepoint
Each month for 9 months
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
To the intervention group, an average glass of Achmoravan extract containing 300 μg of active ingredient in Qazvin Ghazvin Flower Company (three times a day for 7 days late luteal phase) was given to the second group of thyme pills containing 15 grams of thyme, made by Barij Orange Co. . After three months of treatment, the daily registration form will be examined and the physical and mental symptoms will be measured separately before intervention, one month after the intervention, two months after the intervention and three months after the intervention.
Category
Treatment - Drugs

2

Description
To the control group, routine therapy usually used by people of their choice (it should be noted that due to the repeated recurrence of this problem, the overwhelming majority of patients with each cycle do not usually visit the treatment centers and based on their own experience of the methods in Different manners are used). After three months of treatment, the daily registration form will be examined and the physical and mental symptoms will be measured separately before intervention, one month after the intervention, two months after the intervention and three months after the intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Dr Fatemeh Mohammadi - Mehri Kalhor
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Mohammadi
Street address
Ghazvin University of Medical Sciences, Nawab St.
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Research Deputy of Qazvin University of Medical Sciences. Dr. Fatemeh Mohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghazvin University of Medical Sciences, Nawab St.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mohammadi1508@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Mohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghazvin University of Medical Sciences, Nawab St.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mohammadi1508@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mehri Kalhor
Position
Midwife
Other areas of specialty/work
Street address
Kosar Hospital, Valiasr St.
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
mkalhor20@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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