1- Determination of pain severity and duration of pain in female students with dysmenorrhea of Ahvaz Jundishapur University of Medical Sciences
2- Determination of the amount and duration of bleeding in girls with dysmenorrhea of Ahvaz Jundishapur University of Medical Sciences
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct
88 college students are randomly divided into two groups:
(1) a group receiving 15 grams of sesame seeds; (2) a group receiving 15 grams of corn starch . Each participant is monitored over 3 periods. During the first period (menstrual cycle), participants record the severity of dysmenorrhea and its symptoms without any intervention. During the second and third menstrual cycles (for 2 months) one group will receive 15 grams of sesame and the other group will receive 15 grams of corn starch.
Participants/Inclusion and exclusion criteria
Sample acceptance criteria: being single; age 18-26 years; having regular menstrual period between 26-30 days; developing pain several hours before or concurrently with menstruation; menstrual pain less than 3 days; primary menstrual pain in recent years without pathologic Note: having moderate to severe dysmenorrhea according to VAS visual acuity questionnaire; body mass index (BMI) = 18.5 - 24.9 kg / m 2; number of hypertensive strips consumed more than 14;
Sample exclusion criteria: taking oral contraceptives or other steroid hormones; any genital disease; history of any kidney or kidney problems; any diagnosed mental or physical illness.
Intervention groups
- The group receiving 15 grams of sesame seeds 2. The group receiving 15 grams of corn starch .
Main outcome variables
Severity of pain, duration of pain, duration of bleeding, duration of bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190603043807N1
Registration date:2020-02-10, 1398/11/21
Registration timing:prospective
Last update:2020-02-10, 1398/11/21
Update count:0
Registration date
2020-02-10, 1398/11/21
Registrant information
Name
Rezvan Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8330
Email address
amiri.r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of Elaeagnus Angustifolia supplementation on the symptoms of primary dysmenorrhea in female students of Ahvaz Jundishapur university
Public title
Survey the effect of Elaeagnus Angustifolia supplementation on the symptoms of primary dysmenorrhea in female students of Ahvaz Jundishapur university
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single;
Age 18-26 years;
Literacy;
Having regular menstrual period between 26-30 days
Premenstrual syncope several hours ago;
Menstrual pain less than 3 days
primary menstrual pain in recent years
Moderate to severe dysmenorrhea according to visual analogue scale (VAS)
body mass index (BMI) = 18.5-24.9 kg / m2;
duration of menstrual bleeding more than 7 days;
No more than 14 healthbars consumed
no known medical illness
A special diet such as weight loss
obesity
No vegetarianism or water treatment
no tobacco or alcohol use
no regular exercise
Exclusion criteria:
Use of oral contraceptives or other steroid hormones
so any genital tract disease,
a history of any problems or kidney stones,
any physical mental illness has been diagnosed
Age
From 18 years old to 26 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is divided into two groups of receiving placebo and placebo based on 6 blocks of individuals.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both participants in the intervention and control groups and the clinical caregivers associated with the patients were unaware of the type of received sorghum and the received sorghum and corn starch syrups were similar in appearance. The carcasses will be supplemented with placebo and placebo labeled A and B, and before starting the study, the carcasses will be coded by a person other than the researcher as group A containing powdered powder and group B containing corn starch to Lack of researcher information on the type of capsules received by each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
GolestanBlv, Jundishapur University of Medical Sciences
City
ahvaz
Province
Khouzestan
Postal code
15794 – 61357
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.AJUMS.REC.1398.770
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
Intensity of pain
Timepoint
Before the beginning of intervention - the first and the second month after the intervention
Method of measurement
VISUAL ANALOG SCALE
2
Description
Duration of pain
Timepoint
Before the beginning of intervention - the first and the second month after the intervention
Method of measurement
Table of Specifications of Control and Tracking Cycles
3
Description
Duration of bleeding
Timepoint
Before the beginning of intervention - the first and the second month after the intervention
Method of measurement
Higam chart
4
Description
The severity of the bleeding
Timepoint
Before the beginning of intervention - the first and the second month after the intervention
Method of measurement
Higam chart
Secondary outcomes
1
Description
Body Mass Index
Timepoint
Before the intervention, the first month and the second after the intervention
Method of measurement
Weight (kg) to square (m)
Intervention groups
1
Description
Intervention group: Group receiving sachet 15 g. Each participant is monitored over 3 periods. During the first period (menstrual cycle), participants record the severity of dysmenorrhea and its symptoms without any intervention. During the second and third menstrual cycles (for 2 months) they will receive a 15 gram sachet daily. Then, the severity of pain and bleeding are assessed. Demographic characteristics including age, height, weight, waist circumference, girth, physical activity level (PAL) are measured by the Metabolic Equivalent Physical Activity Questionnaire (MET), The Higg chart will assess the visual acuity questionnaire (VAS) to measure the severity and duration of bleeding.
Category
Treatment - Drugs
2
Description
Control group: The group receiving sachets containing 15 grams of corn starch. Each participant is monitored over 3 periods. During the first period (menstrual cycle), participants record the severity of dysmenorrhea and its symptoms without any intervention. During the second and third menstrual cycles (for 2 months) they will receive 15 grams of corn starch daily. They are then assessed for severity of pain and bleeding. Questionnaires on demographic characteristics including age, height, weight, waist circumference, girth, physical activity level (PAL) by Metabolic Physical Activity Questionnaire (MET), Higg chart for severity and bleeding period, pain assessment questionnaire The vas will be reviewed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory of Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilae
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Email
Marziezilae67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamed Badawi
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, 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
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilae
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
Marziezilae67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilae
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
Marziezilae67@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilae
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
Marziezilae67@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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