Comparative study on the effect of Matricaria CHamomile capsule and Achillea Millefolium capsule on primary dysmenorrhea intensity in university students.
Comparison of the effect of Matricaria Chamomile capsule and Achillea Millefolium capsule on primary dysmenorrhea intensity in university students.
Design
This is a randomized, parallel double blinded clinical trial in the third phase of the study, which will be conducted on 60 university students and its results will be measured.
Settings and conduct
The Research community is university students of Kurdistan Medical Sciences Dormitories. Initially, one month before giving the medications, the demographic and menstrual characteristics of the participants were assessed with a questionnaire and Visual Analog Scale; then they are randomly divided into two equal groups using the envelope A and B containing the capsule of camomile and capsule of the Achillea Millefolium. participants and researcher do not know the nature of drugs, The researcher evaluate the out comes in the first three days of one month and two month of menstruation after taking capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Single; Starting a menstrual period at the age of 11 to 17; Having a score of 4 to 10 for menstrual pain according to Visual Analoge Scale
Exclusion criteria: Abnormal uterine bleeding during the study; Epilepsy; Coagulation disorder; Allergic Asthma; Pelvic tumor; History of mental illness; consume benzodiazepines; Barbiturats; Narcotics; Anticoagulant; Theophylline; Hormonal drugs in the past three months.
Intervention groups
Matricaria CHamomile consumer group: consume Chamomile capsules 250 mg every 8 hours during the first three days of their menstrual two consecutive cycles.
Achillea Millefolium consumer group: consume Achillea Millefolium capsules 150 mg every 8 hours during the first three days of their menstrual two consecutive cycles.
Main outcome variables
Primary dysmenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171225038058N1
Registration date:2018-03-09, 1396/12/18
Registration timing:registered_while_recruiting
Last update:2018-03-09, 1396/12/18
Update count:0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
shiva radfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4331 4753
Email address
shiva.radfar@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2018-01-20, 1396/10/30
Actual recruitment end date
2018-04-20, 1397/01/31
Trial completion date
empty
Scientific title
Comparative study on the effect of Matricaria CHamomile capsule and Achillea Millefolium capsule on primary dysmenorrhea intensity in university students.
Public title
Compare the effect of Matricaria CHamomile capsule and Achillea Millefolium capsule on menestural pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be single
Their menstruation start at the age of 11 to 17
Regular menstrual cycles every 21-35 days
A score of 4 to 10 for menstrual pain according to the visual analogue scale
Volunteered to participate in the study
Exclusion criteria:
Have Abnormal bleeding
Have history of any Herbal allergy
Have Epilepsy
Have Coagulation disorder
Have Allergic asthma
Have Digestive diseases
Have Liver disease
Have Renal disease
Have Ovarian cyst
Have Myoma
Have pelvic tumor
Have Endometriosis
Consume Benzodiazepines
Consume Barbiturates
Consume Narcotics
ConsumeTricyclic antidepressants
Consume Anticoagulants
Consume Theophylline
Consume Steroid hormones drugs
Oral contraceptive pills in the last three months were consumed
Consume Alcohol
Known Mental illness
Have Pelvic inflammatory disease
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Initialy one month before taking CHamomile capsule and Achillea Millefolium capsule, demographic and menstrual characteristic questionnaire and the visual Analog Scale will be given to eligible university students and asked them to complete it, in the first three days of menstrual cycle before taking medications.Then envelopes containing 250 mg Matricaria CHamomile capsule or capsule containing150 mg hydro alcoholic extract of Achillea Millefolium made by Kermanshah College of Pharmacy and named as code A or code B is distributed among participants by colleague researcher. Each code represents the existence of one of a variety of capsules inside the envelope and the researcher does not know which of the participants will use the envelope A or the envelope B. Only the pharmacist knows the nature of envelopes contain capsules. researcher, her colleague and participants are unaware of of the type of capsules.
Blinding (investigator's opinion)
Double blinded
Blinding description
By sealing a sealed envelope; individuals may randomly build a Kermanshah Pharmacy School in the capsule group of 250 mg of Matricaria CHamomile, Kermanshah Pharmacy Department or in the group of Achillea Millefolium hydro-alcoholic capsules of Kermanshah, Color, size and aroma are quite similar and will be provided by the research collaborator. Apart from the pharmacist, the investigator or the participants will not know the nature of the medications.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences; Pasdaran Blov
City
sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.MUK.REC.1396.326
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Primary dysmenorrhea intensity
Timepoint
Before intevention، 1, 2, 4, 6 hours after intervention.
Method of measurement
Visulal Analogue Scale
Secondary outcomes
1
Description
The amount of menstrual bleeding
Timepoint
Before intervention and at the end of the third day of the first cycle and the second cycle of menstruation, after taking the Matricaria CHamomile capsule and Achillea Millefolium capsule
Method of measurement
Pictorial blood assessment chart
2
Description
Side effects of taking the Matricaria CHamomile capsule and Achillea Millefolium capsule
Timepoint
At the end of the third day of the first cycle and the second cycle of menstruation, after taking the Matricaria CHamomile capsule and Achillea Millefolium capsule.
Method of measurement
Questionnaire
3
Description
The number of menstruation days
Timepoint
Before intervention and at the end of the second menstrual cycle after intervention
Method of measurement
The questionnaire based on the number of menstrual days
4
Description
Side effects of taking the Matricaria CHamomile capsule and Achillea Millefolium capsule
Timepoint
At the end of the second menstrual cycle after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
intervention group: Oral capsule 150 mg of Achillea Millefolium (constructed at Kermanshah Pharmacy Faculty) is takan every 8 hours after meal during the first 3 days of menstruation in the first and second cycles of their menstruation.
Category
Treatment - Drugs
2
Description
Control group: Oral capsule 250 mg of Matricaria CHamomile (constructed at Kermanshah Pharmacy Faculty) is taken every 8 hours after meal during the first 3 days of menstruation in their first and second cycle of menstruation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences
Full name of responsible person
Azad Zand salimi
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۷۷۱۵۱۷۵
Phone
+98 87 3366 4600
Email
info@uok.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Farzin Razaee
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۷۷۱۵۱۷۵
Phone
+98 87 3366 4653
Fax
Email
f.razaee@muk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Shiva Radtar
Position
دانشجوی کارشناسی ارشد مامائی
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۷۷۱۵۱۷۵
Phone
+98 87 3366 4600
Email
Shivaradfar53@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Laila Hashemi nasab
Position
University faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kurdistan University of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
۶۶۱۷۷۱۵۱۷۵
Phone
+98 87 3366 4600
Email
hasheminasab.l.2014@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan university of Medical Sciences
Full name of responsible person
SHiva Radfar
Position
Midwifery Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kurdistan university of Medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
۷۳۷۱۴۴۶۹۶۴
Phone
+98 71 4331 4753
Email
Shivaradfar53@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