1. Home
  2. Approved trials
  3. » فارسی

The effect of oral use of Mentha Longifolia capsule on the symptoms of premenstrual syndrome and primary dysmenorrhea

Protocol summary

Study aim
Determining the effect of mint oral capsule on premenstrual syndrome and primary dysmenorrhea
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 3 on 64 patients. PASS software will be used for randomization.
Settings and conduct
Sampling will be done in the dormitories of Mashhad University of Medical Sciences. Both intervention and control groups are monitored for 2 months for definitive diagnosis of dysmenorrhea and PMS. Then, 7 days before the onset of menstruation until the first 3 days of menstruation, they will receive one 750 mg capsule daily for two cycles, which before and three hours after taking the drug, the pain intensity using the pain visual scale and Pain duration will be recorded using the Cox scale. Symptoms of PMS will be measured by the premenstrual calendar form. 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
Inclusion criteria: being Iranian and single, living in the dormitories of Mashhad University of Medical Sciences, regular menstruation, age 18-35 years, having PMS and dysmenorrhea at the same time, no specific disease, no medication, no Allergy to mint. Withdrawal conditions: Discontinuation or irregular use of medication, BMI greater than 30, Depression, Severe stress and anxiety, Experience of an unfortunate or stressful accident while studying
Intervention groups
The intervention group was treated with mint capsule, each capsule containing 750 mg of mint extract, 1 dose daily from 7 days before menstruation to the first three days of menstruation for 2 months. Control group during this period will receive the placebo capsule at the same conditions.
Main outcome variables
The mean total score of PMS symptoms؛ the severity and duration of dysmenorrhea.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210630051749N1
Registration date: 2021-07-05, 1400/04/14
Registration timing: prospective

Last update: 2021-07-05, 1400/04/14
Update count: 0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Mahsa Houra
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
houram982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2022-01-10, 1400/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral use of Mentha Longifolia capsule on the symptoms of premenstrual syndrome and primary dysmenorrhea
Public title
The effect of oral use of Mentha Longifolia capsule on the symptoms of premenstrual and the severity and duration of menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian and single. Be a resident of the dormitories of Mashhad University of Medical Sciences. Have regular menstruation Have premenstrual syndrome and primary dysmenorrhea at the same time. Be 18-35 years old. No medication No allergies to mint No alcohol or drugs or tobacco No diet No disease
Exclusion criteria:
Discontinuation of medication or irregular use of medication (not taking medication twice or more) Have a BMI of more than 30. Be a professional athlete. Suffer from depression, stress and anxiety . Experience an unfortunate or stressful event while studying. Has used traditional medicine methods to reduce symptoms and improve pain. Married while studying.
Age
From 18 years old to 35 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: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The research units are easily selected and divided into two groups receiving mint capsules and placebo by random allocation of block type and using PASS software. The drug concealment method is coded in the same package in terms of shape and design.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Researchers, participants, and the Data Safety and Supervision Committee will keep blind in this study. They will have no information about the attribution of individuals to groups.
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
Khorasan Razavi, Mashhad, Daneshgah St., Ph.D. Crossroads, Ibn Sina St., School of Nursing and Midwifery
City
مشهد
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2021-06-30, 1400/04/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.029

Health conditions studied

1

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

2

Description of health condition studied
Premenstrual syndrome
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen

Primary outcomes

1

Description
Mean score of total premenstrual syndrome symptoms, severity and duration of dysmenorrhea
Timepoint
Mean score of total symptoms of premenstrual syndrome, severity and duration of dysmenorrhea at the beginning of the study (before the intervention) and 1 and 2 months after the intervention
Method of measurement
The mean total score of premenstrual syndrome symptoms will be assessed by COPE premenstrual events calendar form and the severity and duration of dysmenorrhea in the first and second months of the treatment cycle, by visual pain scale and COX scale and by patients' self-report.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, mint oral capsule will be used once a day from 7 days before the start of menstruation until the first 3 days of menstruation.
Category
Treatment - Drugs

2

Description
Control group: In the control group, mint oral capsule will be used once a day from 7 days before the start of menstruation until the first 3 days of menstruation.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University Medical Sciences_Baharestan enghelab Dormitory
Full name of responsible person
Zolfaghar Yaghoubi
Street address
Mashhad, Vakilabad Boulevard, Bahonar St., Medical Sciences Dormitory
City
مشهد
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 8299
Email
YaghoubiFZ1@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Razavi Khorasan Province, Mashhad, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Tafaghodim@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
Samira Ebrahimzadehzagami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Razavi Khorasan Province, Mashhad, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
EbrahimzadehzagamiS@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samira Ebrahimzadehzagami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Razavi Khorasan Province, Mashhad, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
EbrahimzadehzagamiS@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahsa Houra
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Razavi Khorasan Province, Mashhad, Daneshgah Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Houram982@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
Loading...