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Investigating the effect of oral capsule of Apricot Kernel seed oil on primary dysmenorrhea

Protocol summary

Study aim
Determining the effect of oral capsule of apricot kernel oil on the intensity of early painful menstrual pain
Design
Clinical trial with control group, double blind, randomized, on 60 patients. For randomization, simple random allocation by coin flipping method was used.
Settings and conduct
Ferdowsi University of Mashhad dormitory. Medicine and placebo are given for 2 menstrual cycles. in each cycle for 5 days In this research, according to the order of entering the samples into the research, people with odd number of drug A and even number of drug B will be given (it should be mentioned that determining the drug with odd and even number is done by lottery).
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Age 18 to 35 years, being single, onset of menstrual pain before the age of 20, experiencing pain and symptoms of moderate and severe dysmenorrhea, monthly bleeding and its regularity, low and moderate bleeding during menstruation, not suffering from chronic diseases, not having a positive history of inflammatory diseases Pelvis, myoma and pelvic tumors, not having a history of gynecological surgeries or abdominal surgery, not using oral contraceptives Exclusion criteria: Unwillingness to continue the research, not using the correct medicinal supplement and taking any medication effective on dysmenorrhea, duration of dysmenorrhea longer than the normal time defined for primary dysmenorrhea.
Intervention groups
Students with primary dysmenorrhea are divided into 2 intervention and control groups. The intervention group received apricot kernel oil capsules and the control group received placebo capsules.
Main outcome variables
Pain intensity; duration of pain; accompanying physical symptoms; Bleeding rate.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230615058488N1
Registration date: 2023-06-22, 1402/04/01
Registration timing: prospective

Last update: 2023-06-22, 1402/04/01
Update count: 0
Registration date
2023-06-22, 1402/04/01
Registrant information
Name
Shamim Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5525 7570
Email address
eskandarish992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of oral capsule of Apricot Kernel seed oil on primary dysmenorrhea
Public title
Investigating the effect of apricot kernel oil on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 35 years, being single, the onset of menstrual pain before the age of 20 (primary dysmenorrhea usually affects girls under 20 years old), experiencing pain and symptoms of moderate and severe dysmenorrhea, monthly bleeding and its regularity with intervals of 21 to 35 days, Low and moderate bleeding during menstruation (absence of clot discharge), not suffering from chronic diseases (diabetes, hyperthyroidism and hypothyroidism, chronic liver or kidney disease and diagnosed depression, not having a history of gastric or duodenal ulcers), not having a positive history of pelvic inflammatory diseases , myoma and pelvic tumors, not having a history of gynecological surgery or abdominal surgery (including any type of open surgery or laparotomy and laparoscopy in the pelvic area such as cysts, masses, adhesions), not using oral contraceptives, benzodiazepines, barbiturates, narcotics , some antidepressants such as fluoxetine and anticoagulants, not consuming alcohol, not having symptoms such as burning, itching and abnormal discharge in the genital area, not having a history of allergies to medicinal plants, not having experienced major stressors such as the separation of parents or the death of a first-degree relative in In the last six months, not being forced to consume a special diet and professional and heavy sports, not smoking, not having plans to transfer, move, party in another university or graduate during the study period.
Exclusion criteria:
In the event of: unwillingness to continue the research, failure to use the correct medicinal supplement and use of any medication effective on dysmenorrhea, the duration of dysmenorrhea is longer than the normal time defined for primary dysmenorrhea.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation by coin flipping method According to the order of entering the samples into the research, people with odd numbers will be given medicine A and people with even numbers will be given medicine B. For example, the first person entered into the study receives drug number 1 and drug A, and the second person receives drug number 2 and drug B. One of the two drugs A and B is apricot kernel oil and the other is a capsule similar to placebo. It should be mentioned that the determination of the medicine is done by lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, sufficient explanations about the study and that the people will be divided into two groups are given to the subjects. The first person entered into the study is given drug A and the second person is given drug B. It should be noted that the people involved in the research, the project manager, the main researcher, the statistical consultant professor do not know which of the two drugs A and B are apricot kernel oil and which one is the placebo. Only the pharmacist consultant is aware of this matter.
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 14, No 5, Arian building, Majidiyeh 33/8 street
City
Mashhad
Province
Razavi Khorasan
Postal code
9186366964
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.035

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea

Primary outcomes

1

Description
Dysmenorrhoea pain intensity
Timepoint
The beginning of the study, the end of the first menstrual cycle and the end of the second menstrual cycle
Method of measurement
Visual Analogue Scale

2

Description
Frequency of physical symptoms of dysmenorrhea
Timepoint
The beginning of the study, the end of the first menstrual cycle and the end of the second menstrual cycle
Method of measurement
Standard verbal multidimensional scoring system

3

Description
Duration of primary dysmenorrhoea pain
Timepoint
The beginning of the study, the end of the first menstrual cycle and the end of the second menstrual cycle
Method of measurement
Cox Menstrual Scale

Secondary outcomes

1

Description
The amount of menstrual bleeding
Timepoint
Before starting the intervention, the end of the first menstrual cycle and the end of the second menstrual cycle
Method of measurement
Higham chart

Intervention groups

1

Description
Intervention group: Students with primary dysmenorrhea who take 900 mg apricot kernel oil oral soft gelatin capsule for 2 menstrual cycles and each cycle for 5 days (2 days before menstruation to 3 days after menstruation).
Category
Treatment - Drugs

2

Description
Control group: Students with primary dysmenorrhea who take the placebo soft gelatin capsule, which is the same shape and size as the apricot kernel oil capsule, for 2 menstrual cycles and each cycle for 5 days (2 days before the onset of menstruation to 3 days after the onset of menstruation) they consume
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad dormitory
Full name of responsible person
Shamim Eskandari
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 5000
Email
pr@um.ac.ir
Web page address
https://www.um.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Talat Khadivzadeh
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Web page address
https://nurse.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
Mahboobeh Firoozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
firoozim@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboobeh Firoozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Street, Doctor's Crossroad, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
Email
firoozim@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shamim Eskandari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 14, No 5, Arian building, Majidiyeh 33/8 street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9186366964
Phone
+98 51 5525 7570
Fax
Email
Eskandarish992@mums.ac.ir

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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