Determining the effect of hofarikun vegetable oil on the severity of primary dysmenorrhea
Design
A clinical trial with a control group, with parallel groups, three blind strains, randomized based on the table of random numbers and phase 3 will be conducted on 100 girls with primary dysmenorrhea.
Settings and conduct
This study will be conducted in the dormitories affiliated with Jundishapur University of Medical Sciences, Ahvaz. First, the patients will be followed up for 2 consecutive cycles, in terms of determining grade 2 or 3 dysmenorrhea. Then, 100 students were randomly divided into two intervention and control groups after being diagnosed with grade 2 or 3 dysmenorrhea.
Participants/Inclusion and exclusion criteria
1- Has grade 2 and 3 primary dysmenorrhea based on multidimensional speech criteria
2- Full consent to participate in the study
3- Regular menstrual cycles with intervals of 21 to 35 days
4- Menstrual bleeding without clots (light and moderate bleeding)
5- The onset and duration of primary dysmenorrhea from a few hours before menstruation to the second day of bleeding
6- History of allergy to herbal medicines
7- Absence of stressful factors in the last two months, special dietary needs
8- No history of pelvic inflammatory disease, myoma and pelvic tumors
Intervention groups
For the intervention group, Hofarikun oil produced by Zardband company and of high quality is purchased. For the control group, paraffin oil will be used. How to complete the checklist and how to take medicines will be taught by the researcher to the patients in both intervention and control groups. In such a way that the patient applies 5 drops of the oil from 5 days before menstruation to 2 days after the start of menstruation and for 2 consecutive cycles and every day 5 drops locally and for 15 minutes in the upper part of the pubis, in a circular manner.
Main outcome variables
intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231017059753N2
Registration date:2024-01-18, 1402/10/28
Registration timing:prospective
Last update:2024-01-18, 1402/10/28
Update count:0
Registration date
2024-01-18, 1402/10/28
Registrant information
Name
leila bozorgian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 0240
Email address
liela.bozorgian1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of Hypericum perforatum Plant oil on the severity pain of primary dysmenorrhea
Public title
the effect of Hypericum perforatum Plant oil on the severity pain of primary dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from grade 2 and 3 primary dysmenorrhea according to verbal multidimensional criteria
Female students aged 17-30 years
Absence of medical illness (diabetes, blood pressure, epilepsy, any kind of heart disease, rheumatism, and neurological diseases...)
Has grade 2 and 3 primary dysmenorrhea based on multidimensional speech criteria
Full consent to participate in the studyf
Regular menstrual cycles with intervals of 21 to 35 days6- Menstrual bleeding without clots (light and moderate bleeding)
Menstrual bleeding without clots (light and moderate bleeding)
The onset and duration of primary dysmenorrhea from a few hours before menstruation to the second day of bleeding
- Not using anticoagulants, narcotics, benzodiazepines
Not using contraceptive pills, painkillers and other herbal medicines as well as relaxation methods or acupressure to relieve primary dysmenorrhea.
History of allergy to herbal medicines
Absence of stressful factors in the last two months, special dietary needs
- No history of pelvic inflammatory disease, myoma and pelvic tumors
Exclusion criteria:
Continuous use of nutritional supplements and vitamins
Age
From 17 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be in the form of random block sampling based on the purpose and according to the study entry criteria. We consider the block size to be 5. Therefore, based on the sample size, we will have 20 blocks. When sampling starts, the first block will be randomly assigned one of the codes A or B. Based on the received code of the first block, the second code will be sent to the second block, the first code will be sent to the third block, the second code will be sent to the fourth block, and so on until the end of the 20th block.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Hypericum perforatum oil and paraffin oil (placebo) will be matched by the pharmacist in terms of appearance, color, size, smell, and code (A and B). The researcher, the service provider, the data analyst, and the patient are unaware of the type of drug used, and only the pharmacist will be aware of this coding.
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
Ahvaz Golestan, North Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Approval date
2023-12-15, 1402/09/24
Ethics committee reference number
IR.AJUMS.REC.1402.487
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N73.8
ICD-10 code description
Other specified female pelvic inflammatory diseases
Primary outcomes
1
Description
intensity of pain
Timepoint
Subjects will fill the questionnaires half an hour after oil massage during the second day of menstruation in both consecutive cycles.
Method of measurement
McGill pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The drug used for the intervention group is hofaricon oil. This drug was manufactured by Danesh Banyan Zardband company with high quality and was purchased from this company. The patient will be instructed to apply 5 drops of the oil from 5 days before menstruation to 2 days after the onset of menstruation and for 2 consecutive cycles and every day 5 drops locally for 15 minutes on the upper part of the pubis. The face should be massaged circularly from the center point to the size of the palm.
Category
Treatment - Drugs
2
Description
Control group: Control group: The drug used for the control group is paraffin oil. The patient will be instructed to apply 5 drops of the oil from 5 days before menstruation to 2 days after the onset of menstruation and for 2 consecutive cycles and every day 5 drops locally for 15 minutes on the upper part of the pubis. The face should be massaged circularly from the center point to the size of the palm.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls' dormitories affiliated to Ahvaz University of Medical Sciences
Full name of responsible person
leila bozorgian
Street address
Ahvaz, Golestan, North Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3314 0000
Email
journal_ajums@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakir Kish
Street address
Ahvaz, Golestan, North Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3314 0000
Email
journal_ajums@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
leila bozorgian
Position
PhD student in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Golestan, North Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3314 0000
Email
journal_ajums@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
leila bozorgian
Position
PhD student in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz, Golestan, North Esfand St
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3314 0000
Email
liela.bozorgian1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
liela bozorgian
Position
PhD student in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Ahvaz Golestan, North Esfand St
City
ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3314 0000
Email
liela.bozorgian1@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