A clinical trial with a control group, with cross-over groups, double-blind, randomized, phase 3 on 42 patients, random block allocation method was used for randomization.
Settings and conduct
This project was carried out in the Yazd Health Center. Patients are randomly assigned to three treatment groups A, B, and C, and they receive one of the capsules of Mentha longifolia L or mefenamic acid or placebo every 6 hours with the onset of symptoms for three days.
Participants/Inclusion and exclusion criteria
Patients with moderate to severe dysmenorrhoea pain who do not receive NSAID drugs and do not have allergy to herbal products.
Intervention groups
To investigate the effect of Mentha longifolia L plant on reducing pain caused by dysmenorrhea, 42 patients were randomly assigned to three treatment groups A, B and C, and the patient received one of Mentha longifolia L plant capsules or mefenamic acid or placebo in each menstrual cycle.
Main outcome variables
Therapeutic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N8
Registration date:2023-10-08, 1402/07/16
Registration timing:retrospective
Last update:2023-10-08, 1402/07/16
Update count:0
Registration date
2023-10-08, 1402/07/16
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-27, 1397/09/06
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Mentha longifolia L. efficacy on decrease of dysmenorrhea pain
Public title
Evaluation of Mentha longifolia L on dysmenorrhea pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women's 15 to 45 years old
Moderate to severe dysmenorrhea pain
Exclusion criteria:
Patients with mild or secondary dysmenorrhea pain
Patients have received one of the NSAID drugs.
Hypersensitivity to Mentha longifolia L
Pregnancy and lactation
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
3
In each menstrual cycle, a person will be placed in one of three groups.
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 42 patients are randomly divided into three treatment groups (A ,B and C). Block random allocation method will be used for random allocation. In this study, 7 blocks of 6 are considered. The generated permutations include repeated letters A, B and C (eg ABACAB). These permutations are generated with the help of Random allocation software version 1. For this purpose, the list prepared by the software is from 1 to 42, which are arranged in 7 blocks of six regularly. To run this software output, we give the first qualified person number 1 and the last person will receive number 42. In order to be blind, the random allocation of this list is given to another person outside the study, and by sending a text message before assigning the type of treatment, the eligible person is asked according to the number, and thus the people enter the study. Also in the software output, both numbers 1 to 42 and permutations of the letters A, B and C can be seen.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, clinical caregivers and outcome assessors were unaware of the type of medication patients were receiving. Patients in three groups received the medication in the same package
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.134
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
Dysmenorrhoea pain
Timepoint
Days 0 and 3
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with primary dysmenorrhoea with moderate to severe severity use one capsule of mefenamic acid every 6 hours for up to 3 days.
Category
Treatment - Drugs
2
Description
Intervention group: Patients with primary dysmenorrhoea with moderate to severe severity use two capsules of Mentha longifolia (Manufactured in Yazd Pharmacy Faculty) every 6 hours for up to 3 days.
Category
Treatment - Drugs
3
Description
Control group: Patients with primary dysmenorrhoea with moderate to severe severity use one placebo capsule (Manufactured in Yazd Pharmacy Faculty) every 6 hours for up to 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Health Center
Full name of responsible person
Behrooz Heydari
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghouei
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnan Blvd Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnan Blvd Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of medical sciences,Shohadaye Gomnam Blvd,Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.