Protocol summary

Study aim
Determination of the effect of supplementation of pms50 on psychological symptoms of premenstrual syndrome
Design
The present study is a clinical trial of phase 3, randomized, double-blind, and parallel, which will be performed on 50 girls with premenstrual syndrome who have criteria for entering the study. The participants were randomly assigned to dice Two groups of intervention and control will be divided.
Settings and conduct
This study will be performed on female students of Ahwaz University of Medical Sciences. At first, anthropometric measurements of individuals such as weight, height, BMI, abdomen and Durlegan were measured and a 3-day dietary recall questionnaire and a physical activity questionnaire were recorded. To be The standard Rozgovnol and Bonlander questionnaires were given to individuals, and the questionnaire was followed by a three-day diet.
Participants/Inclusion and exclusion criteria
Entry criteria: single, premenstrual syndrome, regular menstrual cycle, age range 25-35, weight range 55-65kg, normal BMI ranging from18.5 to 24.9 kg/m2.Exit criteria: Marriage, pregnancy, lactation, irregular menstrual cycle, age below 25 or over 35, weight below 55 or above 65kg, taking psychological drugs andUnwillingness of the participant to continue the research
Intervention groups
Participants of female students of Ahvaz University of Medical Sciences were selected for premenstrual syndrome. During the three consecutive menstrual cycles, from one week before menstruation to the end of the menstrual cycle, two tablets (one morning and one night), the supplementary intervention group PMS50 and the placebo control group.
Main outcome variables
Symptoms include restlessness, depression, anger, irritability, transient mood, anxiety and worry, feeling of frustration, loneliness and isolation, feeling unwell, appetite increase or decrease, tenderness to salty or sweet foods

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181218042038N1
Registration date: 2019-01-15, 1397/10/25
Registration timing: registered_while_recruiting

Last update: 2019-01-15, 1397/10/25
Update count: 0
Registration date
2019-01-15, 1397/10/25
Registrant information
Name
Fatemeh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 0649
Email address
sadeghi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pms50 supplement on the psychological symptoms of girls with premenstrual syndrome
Public title
The effect of pms50 supplement on the psychological symptoms of premenstrual syndrom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unmarried Premenstrual syndrome Regular menstrual cycle Age range 25-35 Weight range 55-65kg Normal BMI ranging from18.5 to 24.9 kg/m2
Exclusion criteria:
Being married Pregnancy Lactation Irregular menstrual cycle Age younger than 25 or over 35 years old Weight below 55 or above 65kg Use of psychological drugs Unwillingness of the participant to continue the research
Age
From 25 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple (assigning a person to a particular group completely randomly) through dice throwing
Blinding (investigator's opinion)
Double blinded
Blinding description
The type of blindness in this study will be double blind. Before starting the study, by dicing throwing by someone other than the researcher, the subjects are in the intervention group and the control group and the supplementary delivery to the patients is also performed by an individual other than the investigator. The study of patients and researcher who plays the role of collecting and analyzing data is kept blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.AJUMS.REC.1397.525

Health conditions studied

1

Description of health condition studied
Psychological symptoms of premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Restlessness score in the Rossignol & Bonlander Questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

2

Description
Depression score in the Russugnol and Bonlander questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

3

Description
Anger Score in the Rossignol & Bonlander Questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

4

Description
Irritability score in the Russugnol and Bonlander questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

5

Description
Anxiety score in the Rossignol & Bonlander Questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

6

Description
Transient mood Score in the Rossignol & Bonlander Questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

7

Description
Feeling frustrated score in the Rossignol & Bonlander Questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

8

Description
Loneliness and isolation score in the Russugnol and Bonlander Questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

9

Description
The score for the lack of attractiveness in the Russugnol and Bonlander questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

10

Description
Increased or decreased appetite score in the Russugnol and Bonlander questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

11

Description
Score the tendency to salty or sweet foods in the Russugnol and Bonlander questionnaire
Timepoint
The beginning and the end of the study
Method of measurement
Rossignol & Bonlander Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Supplement pms50 containing vitamins B1, B2, B6, E, D3, magnesium oxide and Vitagnus extract, two daily pills (one morning and one night) from one week before menstruation to the end of menstruation for three consecutive menstrual cycles
Category
Treatment - Drugs

2

Description
Control group: Placebo, starch, two daily pills (one morning and one night) from one week before menstruation to the end of menstruation for three consecutive menstrual cycles
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh sadeghi
Street address
Golestan highway
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 7333 8383
Email
sadeghi.f@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badawi
Street address
Golestan highway
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3633 7075
Fax
+98 61 3633 4415
Email
badavi-m@ajums.ac.ir
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
Fatemeh sadeghi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan highway
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 7333 8383
Email
sadeghi.f@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad zare javid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan highway
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 7333 1783
Email
ahmaddjavid@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh sadeghi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan highway
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 7333 8383
Email
sadeghi.f@ajums.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
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