Investigating the effect of frankincense capsules on premenstrual syndrome and primary dysmenorrhea of students of Mashhad University of Medical Sciences
Determining the effect of frankincense capsules on PMS and primary dysmenorrhea
Design
A controlled, parallel-group, triple-blind, randomized, phase 2 clinical trial on 62 patients. PASS software will be used for randomization.
Settings and conduct
Sampling will be done in the hostels of Mashhad University of Medical Sciences. Both intervention and control groups are monitored for 2 months in order to diagnose dysmenorrhea and premenstrual syndrome. people will receive three 500 mg capsules daily for 2 cycles from 7 days before the start of menstruation to the first 3 days of menstruation. Pain intensity by VAS scale And the duration of pain by Cox scale will be recorded .The symptoms of premenstrual syndrome will be measured by COPE form. Finally, the symptoms of PMS and the severity and duration of dysmenorrhea before, one and two months after the intervention will be compared with the control group.
Participants/Inclusion and exclusion criteria
1.Age 18 to 35.2.Regular menstrual cycles.3.Suffering from PMS and primary moderate to severe dysmenorrhea at the same time.4.single.5.Resident in the dormitory.6.Not taking certain drugs.7.Not using alcohol or drugs and tobacco.8.Not having depression, anxiety and extreme stress.9.Lack of diet.10.Not using medicinal and traditional treatments to reduce the symptoms of PMS and dysmenorrhea.11.BMI less than 30.12.Absence of specific medical disease.13.Absence of known gynecological issues.14.The absence of stressful events in the past 6 months.15.Not engaging in sports professionally.
Intervention groups
The intervention group receive frankincense capsules (500 mg) 3 times a day from 7 days before the onset of menstruation to the first 3 days of menstruation for 2 months.The control group will receive the placebo capsule.
Main outcome variables
Average total score of premenstrual syndrome symptoms and severity and duration of dysmenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230702058648N1
Registration date:2023-08-21, 1402/05/30
Registration timing:prospective
Last update:2023-08-21, 1402/05/30
Update count:0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
Mohaddeseh Borhaninasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
borhaninasabm4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of frankincense capsules on premenstrual syndrome and primary dysmenorrhea of students of Mashhad University of Medical Sciences
Public title
Investigating the effect of frankincense capsules on premenstrual syndrome and menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age 18 to 35 years. 2. Regular menstrual cycles. 3. Suffering from premenstrual syndrome and primary moderate to severe dysmenorrhea at the same time. 4. Being single. 5. Resident in the dormitory of Mashhad University of Medical Sciences. 6. Not taking certain drugs. 7. Not using alcohol or drugs and tobacco. 8. Not having depression, anxiety and extreme stress. 9. Lack of diet. 10. Not using medicinal and traditional treatments to reduce the symptoms of premenstrual syndrome and dysmenorrhea. 11. BMI less than 30. 12. Absence of specific medical disease. 13. Absence of known gynecological issues such as fibroids and endometriosis. 14. The absence of stressful events in the past 6 months. 15. Not engaging in sports professionally.
Exclusion criteria:
1. Age 18 to 35 years. 2. Regular menstrual cycles. 3. Suffering from premenstrual syndrome and primary moderate to severe dysmenorrhea at the same time. 4. Being single. 5. Resident in the dormitory of Mashhad University of Medical Sciences. 6. Not taking certain drugs. 7. Not using alcohol or drugs and tobacco. 8. Not having depression, anxiety and extreme stress. 9. Lack of diet. 10. Not using medicinal and traditional treatments to reduce the symptoms of premenstrual syndrome and dysmenorrhea. 11. BMI less than 30. 12. Absence of specific medical disease. 13. Absence of known gynecological issues such as fibroids and endometriosis. 14. The absence of stressful events in the past 6 months. 15. Not engaging in sports professionally.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple.
Allocation Concealment method:
In order to conceal, frankincense and placebo oral capsules are provided to the researcher by the pharmacist consultant in similar forms (appearance, color and packaging) and with two different codes, and only the pharmacist consultant knows about it.
The method used to generate a random allocation sequence by mentioning the name of the software or site used:
After confirming the presence of premenstrual syndrome and early dysmenorrhea in the research units and according to the entry and exit criteria, people will be randomly assigned to two groups using the PASS software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Allocation Concealment method:
In order to conceal, frankincense and placebo oral capsules are provided to the researcher by the pharmacist consultant in similar forms (appearance, color and packaging) and with two different codes, and only the pharmacist consultant knows about 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
Mashhad Faculty of Nursing and Midwifery, Ibn-e Sina St., Doktora Crossing., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-07-25, 1402/05/03
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.065
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
2
Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Average total score of premenstrual syndrome symptoms
Timepoint
Calculation of the average score of premenstrual syndrome symptoms at the beginning of the study (before the start of the intervention) and 1 and 2 months after the start of the intervention
Method of measurement
The mean total score of premenstrual syndrome symptoms will be evaluated by the Calendar of Premenstrual Events (COPE) form, as self-reported by the patients.
2
Description
Average total score of severity and duration of primary dysmenorrhea
Timepoint
Calculation of the average score of severity and duration of dysmenorrhea at the beginning of the study (before the start of the intervention) and 1 and 2 months after the start of the intervention
Method of measurement
The mean total score of dysmenorrhea intensity by the visual pain scale (VAS) and the mean total score of pain duration by the scale COX menstrual scale will be investigated in the form of self-reporting by patients.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, oral oregano capsules will be used once a day from 7 days before menstruation to the first 3 days of menstruation.
Category
Treatment - Drugs
2
Description
Control group: In the control group, the placebo capsule will be used once a day from 7 days before menstruation to the first 3 days of menstruation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharestan Dormitory., Mashhad University of Medical Sciences Campus
Full name of responsible person
Fatemeh Erfanian
Street address
Baharestan Dormitory., Mashhad University of Medical Sciences Campus., Bahonar St., Vakil Abad Blvd., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3859 1511
Email
ErfanianF@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Erfanian
Street address
Qureshi Building., Central Organization of Mashhad University of Medical Sciences., Daneshgah Ave., Razavi Khorasan Province., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3859 1511
Email
erfanianf@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
Mohaddeseh Borhaninasab
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashhad Faculty of Nursing and Midwifery., Ibn-e Sina St., Doktora Crossing., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
ErfanianF@mums.ac.ir
Phone
+98 51 3859 1511
Email
Borhaninasabm4001@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Erfanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery University, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0513591511
Email
ErfanianF@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohaddeseh Borhaninasab
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery University, Ibn Sina St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Borhaninasabm4001@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