Comparison of the effect of herbal tea with yarrow extract capsule on the severity of primary dysmenorrhea
Design
Clinical trial with randomized, non-blinded parallel groups on 60 female students in two groups receiving yarrow herbal tea and yarrow extract capsules
Settings and conduct
Presentation of yarrow herbal tea and capsule extract to female students living in Gonabad University of Medical Sciences dormitory and evaluation of primary dysmenorrhea pain before and on the first, second and third days in two menstrual cycles
Participants/Inclusion and exclusion criteria
Inclusion criteria: conscious consent, age range 15 to 45 years, regular menstruation at intervals of 21 to 35 days, dysmenorrhea pain score greater than 5, no history of chronic physical diseases, no use of hormonal drugs and birth control pills in three months In the past, no accidents in the last six months, no allergies to herbs and no allergies during the study, the onset of pain at the same time as the onset of menstruation or a few hours before the onset of menstruation and pain lasting up to 48 to 72 hours, no abnormal bleeding Do not use painkillers during the study, use capsules and teas according to the method of work
Conditions for non-entry included: unwillingness to cooperate.
Intervention groups
Yarrow Extract Capsule Group: Receive capsules containing 150 mg of yarrow and take one every 8 hours.
Yarrow herbal tea group: Receive teas containing 4 grams of yarrow and daily consumption of three with a meal with 300 ml of boiling water
Main outcome variables
Severe pain of primary dysmenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180221038821N4
Registration date:2020-11-07, 1399/08/17
Registration timing:prospective
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Iman Ghorbany Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 0576
Email address
ghorbani.i@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Herbal Tea with Achillea Millefolium Capsule on the severity of Primary Dysmenorrhea
Public title
Comparison of the Effect of Herbal Tea with Achillea Millefolium Capsule on the severity of Primary Dysmenorrhea in Students Residing in Dormitories of Gonabad University of Medical Sciences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Being 15 to 45 years old
Having regular menstruation with intervals of 21 to 35 days according to the statements of research units
Having dysmenorrhea pain with a score higher than 5 according to the visual pain scale
No history of physical illnesses such as asthma, allergies, migraines, diabetes, thalassemia, hypertension, thyroid, cardiovascular disease and no pelvic inflammatory disease diagnosed uterine problems such as abnormal bleeding and ovarian cysts based on patient statement
Do not take hormonal drugs and oral contraceptives for the past three months
No accidents during the last six months, according to research units
Lack of sensitivity to medicinal and chemical plants according to the statements of research units
The onset of menstrual cramps coincides with the onset of menstrual bleeding or a few hours before the onset of menstruation and lasts for a maximum of 48 to 72 hours, according to research units.
No abnormal bleeding during the study
Do not use housing while studying
Absence of any effects indicating an allergic reaction based on the researcher's observation and the statements of research units
Use yarrow capsule or tea according to the recommended method
Exclusion criteria:
Reluctance to continue participating in the study
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random method (coin toss) into two groups of consumption of tea (heads) or consumption of yarrow capsules (tails)
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
Ethnical Committee of Gonabad University of Medical Sciences
Street address
Asian Road Rim, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
96916-47161
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.GMU.REC.1399.020
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Pain
Timepoint
At the beginning of the study (before the intervention) and at the end of the first, second and third days of each menstrual cycle
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group receiving Yarrow extract capsule. Yarrow hydroalcoholic extract was obtained with the help of a biochemist and injected in special capsules in the amount of 150 mg. The capsules were taken every eight hours and three times a day for the first to third days of menstruation for two cycles. Yarrow was collected from the nature of the region by a researcher.
Category
Treatment - Drugs
2
Description
Intervention group: group receiving Yarrow herbal Tea. In this group, yarrow plant collected from nature was mixed with candy (for sweetening) and ground. 4 grams of ground yarrow was poured into ready-made tea bags and delivered to the research units. The teas were consumed every eight hours with 300 ml of boiling water and after meals in the first to third days of menstruation for two cycles.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitories for female students of Gonabad University of Medical Sciences
Full name of responsible person
Dr. Javad Bazeli
Street address
Asian Roadside, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3514
Email
info@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosravan
Street address
Asian Road Rim, Gonabad University of Medical Sciences, Deputy of research and technology
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 0576
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5725 0773
Fax
Email
imanghorbany135213@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5725 0773
Fax
Email
imanghorbany135213@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Iman Ghorbany Moghaddam
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No9, Behesht Street, Emam Sajjad Blvd, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691647161
Phone
+98 51 5725 0773
Fax
Email
imanghorbany135213@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data not collected.
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