Determining the effect of hydroalcoholic extract of coriander plant seeds on primary dysmenorrhoea
Design
Randomized Clinical trial, with parallel groups, triple-blind, phase 1 on 70 patients. Random Allocation Software was used for randomization.
Settings and conduct
70 students of Ferdowsi University girls dormitories are divided into two intervention and control groups. The study is triple blind and the participants, researchers and analysts are among the blinded groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
• Be single
• Be in the age range of 18-30 years
• Have regular menstrual cycles
• Have moderate to severe dysmenorrhea
• Do not have a history of pelvic and abdominal disease
• Do not have a history of chronic diseases
• Do not have a history of pain in the abdomen and back except during menstrual bleeding
• Do not have a history of confirmed mental illnesses
• Not having severe mental stress in the last 6 months
• Not allergic to coriander
• Informed consent
Exclusion criteria:
• Unwillingness to continue cooperation
• Occurrence of a severe stressful event during the study period
• Use of contraceptives
• Irregular use of medicine or placebo
• Getting married during the study period
• Performing professional sports activities
• Taking any type of supplement
• Presence of benign breast or uterine cysts
• They have had a history of prostate, breast cancer and ovarian cancer in their first degree relatives
• Use of other herbs or drugs effective on dysmenorrhea
Intervention groups
Intervention group: 35 people from the sample size who are given medicine for five days in two menstrual cycles.
Control group: 35 people from the sample size who are given placebo for five days in two menstrual cycles.
Main outcome variables
Intensity of primary dysmenorrhoea pain - duration of primary dysmenorrhoea pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230315057729N1
Registration date:2023-05-31, 1402/03/10
Registration timing:prospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Zohre Shahri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3261 2156
Email address
shahriz981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydroalcoholic extract of coriander seed on primary dysmenorrhea
Public title
The effect of hydroalcoholic extract of coriander seed on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be single
Be in the age range of 18-30 years
Have regular menstrual cycles
Have moderate to severe dysmenorrhea
Do not have a history of pelvic and abdominal disease
Do not have a history of chronic diseases
Do not have a history of pain in the abdomen and back except during menstrual bleeding
Do not have a history of confirmed mental illnesses
Not having severe mental stress in the last 6 months
Not allergic to coriander
Informed consent to participate in the study
Exclusion criteria:
Unwillingness to continue cooperation
The occurrence of a severe stressful event during the study period
Taking contraceptives
Irregular use of medicine or placebo in the amount of two consecutive doses
Getting married during the study period
Performing professional sports activities
Taking any type of supplement and multivitamin
Presence of benign breast or uterine cysts
They have had a history of prostate cancer, breast cancer and ovarian cancer in their first degree relatives
Use of other herbs or drugs effective on dysmenorrhea
Age
From 18 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation blocks method is used to assign people to the studied groups. Random allocation sequence of people will be done using Random Allocation Software and block size of four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of studied groups. Sealed envelopes are used to hide the assignment. Based on the order of entry of the research units, the envelopes will be opened in order and the assigned group will be revealed.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a triple-blind study, in which participants, researchers and data analysts are among the blind groups of the study. In order to blind people, the drug and placebo are prepared in the form of capsules with completely similar packaging. There are codes on the packages that distinguish the drug from the placebo, and the researcher, research units and analysts are not aware of it.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Unit 11, Hafez Apartment, Farzangan Alley, Nasr Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743764
Approval date
2023-05-15, 1402/02/25
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.018
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 and duration of pain in early painful menstruation
Timepoint
Measuring the intensity and duration of painful menstruation at the end of menstrual bleeding during two consecutive cycles and simultaneously with the start of the drug or placebo.
Method of measurement
Questionnaires made by the researcher. Visual Analogue Scale
Secondary outcomes
1
Description
The amount of menstrual bleeding - duration of menstrual bleeding - physical symptoms associated with menstruation
Timepoint
After the end of menstrual bleeding in two consecutive cycles and at the same time as giving medicine or placebo
Method of measurement
Questionnaires made by the researcher
Intervention groups
1
Description
Intervention group: 35 girls living in the dormitories of Ferdowsi University, who meet the inclusion criteria, were given oral capsules containing hydroalcoholic extract of coriander seeds with a dose of 500 mg for five days in two menstrual cycles. It is prepared and given by the pharmacist consultant professor, and during this time, the effect of the medicine on the intensity and duration of their menstrual pain is measured using designed questionnaires.
Category
Treatment - Drugs
2
Description
Control group: 35 girls living in the dormitories of Ferdowsi University who meet the inclusion criteria will be given an oral capsule containing a placebo (Avisel powder) for five days in two menstrual cycles.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferdowsi University girls dormitories
Full name of responsible person
Zohre Shahri
Street address
Sarai Paradis 2, Danesh Blvd., in front of the Faculty of Literature and Humanities
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
ict@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Talat Khadivzadeh
Street address
Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
relations@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zohre Shahri
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 11, Hafez apartment, Alley in front of Farzanegan High School, Nasr street, Ziba shahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743764
Phone
+98 54 3261 2156
Fax
Email
shahriz981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohre Shahri
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 11, Hafez apartment, Alley in front of Farzanegan High School, Nasr street, Ziba shahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743764
Phone
+98 54 3261 2156
Fax
Email
shahriz981@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zohre Shahri
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 11, Hafez apartment, Alley in front of Farzanegan High School, Nasr street, Ziba shahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743764
Phone
+98 54 3261 2156
Fax
Email
shahriz981@mums.ac.ir
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