Protocol summary

Study aim
comparison of the effect of oral calcium and magnesium on the reduction of pms
Design
Double-blind clinical trial.
Settings and conduct
204 female students of Shahrekord University of Medical Sciences with a definite diagnosis of PMS were divided into a group of68. The first group was given 1000 mg of oral calcium and the second group was given 300 mg of magnesium daily during one week before menstruation. The third group is followed as a control group. Patients will be examined with a questionnaire and checklist during 3 consecutive periods of menstruation in terms of clinical symptoms. The data will be analyzed after collection and the results will be presented in the form of articles and dissertations
Participants/Inclusion and exclusion criteria
Entry criteria: Entry includes being single, regular and normal menstruation with intervals of 21 to 35 days and a duration of 3-7 days during the past six months, not suffering from known physical and mental diseases and not undergoing any type of treatment in order to alleviate the symptoms of the syndrome. Premenstrual during the study period Non-entry criteria: Not having entry criteria
Intervention groups
Student girls living in the dormitory of Shahrekord University of Medical Sciences who, based on the DSM-V criteria (presence of at least 5 of the disease symptoms listed in the questionnaire within 5 days before the start of monthly bleeding, which are present in at least 3 consecutive periods and within several the day after the bleeding disappears) have PMS
Main outcome variables
premenstrual syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160709028844N1
Registration date: 2023-04-26, 1402/02/06
Registration timing: retrospective

Last update: 2023-04-26, 1402/02/06
Update count: 0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Sheida Shabanian
Name of organization / entity
Shaharekord University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 38 3228 4014
Email address
shabanian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
2018-11-21, 1397/08/30
Actual recruitment end date
2019-04-19, 1398/01/30
Trial completion date
2019-06-20, 1398/03/30
Scientific title
Comparative study of the effect of oral calcium and magnesium on the reduction of PMS
Public title
oral calcium and magnesium on the reduction of pms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female students of Shahrekord University of Medical Sciences with definite diagnosis of premenstrual syndrome Not using other treatment methods Willingness to participate in the study Not suffering from known physical and mental diseases single Calendar age 18 to 27 years Regular menstrual cycle of 21 to 35 days Menstruation duration 3-7 days during the last six months In terms of the severity of PMS symptoms, they were matched according to the DSM-V score
Exclusion criteria:
Reluctance to participate in the study Use of other treatment methods
Age
From 18 years old to 27 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 195
Actual sample size reached: 204
Randomization (investigator's opinion)
Randomized
Randomization description
The study was conducted in a double-blind and randomization method using stratified random allocation, so that according to the severity of PMS, the patients were divided into three categories: very severe, moderate to severe, and mild, and in each category, they were randomly assigned to three groups A and B. and C were divided. A total of 204 female students living in the dormitory of Shahrekord University of Medical Sciences with PMS were divided in terms of physical symptoms and psychological symptoms, and as a result, 66 people were in the mild category, 84 people were in the moderate category, and 54 people were in the severe category. The random sequence was obtained through the online randomization program (program address: https://www.sealedenvelope.com/simple-randomiser/v1/lists) And based on the random list, each patient was assigned to one of the groups A, B, and C, respectively. In terms of the severity of premenstrual syndrome, in each group of 68 people, there were an equal number of 22 mild, 28 moderate and 18 severe patients. After filling the consent form, the drugs were prepared by a pharmacologist from Dr. Abedi Pharmaceutical Company and divided into three packages of the same color. And one shape was named with letters A, B and C. Group A contained 1000 mg of calcium, group B contained 300 mg of magnesium, and group C contained selenium as a placebo. The patients and the researcher did not know about the contents of the package.
Blinding (investigator's opinion)
Double blinded
Blinding description
he study was double-blind and the drugs were given to the study subjects in packages of the same shape, A, B, and C, and the patients and the researcher did not know about the contents of the package
Placebo
Used
Assignment
Parallel
Other design features
There is no case

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
No. 4, 36 Yaser Ave Shahrekord Town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815754673
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR.SKUMS.REC.1397.033

Health conditions studied

1

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

Primary outcomes

1

Description
Premenstrual syndrome
Timepoint
The beginning of the study and 1, 2 and 3 months after the study
Method of measurement
PMS diagnostic criteria based on DSM-V

Secondary outcomes

1

Description
Physical and mental symptoms
Timepoint
0 start of study and 1 month, 2 months and 3 months later
Method of measurement
DSM-V

Intervention groups

1

Description
Group A consumed 1000 mg of calcium per day for the study period of 3 cycles from the 15th day of the menstrual cycle or immediately after ovulation to the start of menstrual bleeding, and at the end of the cycle and with the beginning of bleeding, they completed the PSST questionnaire.
Category
Treatment - Drugs

2

Description
Group B consumed 300 mg of magnesium daily for the study period of 3 cycles from the 15th day of the menstrual cycle or immediately after ovulation to the onset of menstrual bleeding, and at the end of the cycle and with the onset of bleeding, they completed the PSST questionnaire
Category
Treatment - Drugs

3

Description
Group C used selenium tablets for placebo for 3 study cycles from the 15th day of the menstrual cycle or immediately after ovulation to the beginning of menstrual bleeding, and at the end of the cycle and with the onset of bleeding, they completed the PSST questionnaire
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
student dormitory
Full name of responsible person
Sheida Shabanian
Street address
rahmatieh .Dormitory for female medical students
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 913 185 8493
Email
shabanian@skums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Reisi Elham
Street address
Rahmatieh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
shabanian@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Ave
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816746633
Phone
+98 38 3222 0016
Email
shabanian@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sheida Shabanian
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Parastar Ave
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
shabanian@skums.acir

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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