Comparison of the effects of Vitagnus capsule, Soy and the combination of Vitagnus and Soy in students with premenstrual syndrome (PMS)
Design
A three-group, randomized double-blind clinical trial
Settings and conduct
This Double-blind and three-group research will be conducted on 108 students living in the dormitory of Mashhad University of Medical Sciences with moderate to severe PMS symptoms. The existence of PMS by the temporary diagnosis form of PMS and the absence of depression, anxiety and severe stress according to the DASS-21 questionnaire were selected as the research unit, and a written consent form will be obtained from them to participate in the study. Then the COPE form will be given to the sample to confirm the diagnosis and severity of PMS for two consecutive menstrual cycles; If the average symptom intensity score is more than 30%, the sample will be included in the study and the people of the research unit will be given Vitagnus capsules, Soy capsules and combined Vitagnus and Soy capsules once a day after breakfast throughout the cycle for 2 menstrual cycles. Within 2 cycles of treatment, a daily condition registration form will be collected and the average intensity of physical, mental and general symptoms as well as the intensity of menstrual pain will be measured in the two cycles before and after the intervention.
Participants/Inclusion and exclusion criteria
Entry criteria: Student living in the dormitory of Mashhad University of Medical Sciences؛ written consent to participate in the study؛ being single؛ age 16-45 years؛ regular menstruation؛ BMI less than 30 kg/m2؛ having symptoms of PMS and
Exclusion criteria: Allergy to Vitagnus and Soy products
Intervention groups
3 groups receiving 500 mg capsules, including Vitagnus capsules, Soy capsules, and combined Vitagnus and Soy capsules
Main outcome variables
Average score of physical, mental and total PMS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220720055514N1
Registration date:2022-08-30, 1401/06/08
Registration timing:prospective
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Roya Partovigolshan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4262 1034
Email address
partovigr992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Vitagnus capsules, Soy and the combination of Vitagnus and Soy in students with premenstrual syndrome
Public title
Comparison of the effect of Vitagnus capsules, Soy and the combination of Vitagnus and Soy in students with premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be a student living in the dormitory of Mashhad University of Medical Sciences
Have written and informed consent to participate in the study
Be of Iranian and Muslim nationality
Be single
Be 16-45 years old
Have regular menstruation with menstrual intervals of 21-38 days and a bleeding period of less than 7 days
Have a BMI less than 30 kg/m2
Have 5 or more than 5 symptoms out of 11 symptoms of the premenstrual syndrome temporary diagnosis form and at least one of the first 4 symptoms of the questionnaire
Do not suffer from physical or mental illness
Do not suffer from severe Depression, Stress and Anxiety according to DASS 21 form
Not taking any special medicine
She has not taken effective drugs (chemical or herbal) on premenstrual syndrome in the last three months
Has not experienced an unfortunate accident in the last 6 months
Not a professional athlete
Do not follow a special diet or vegetarian diet
Not allergic to Vitagnus and Soy products
No history of breast cancer in first degree relatives
Do not consume Alcohol, Cigarettes or any drugs
Exclusion criteria:
Get married while studying
Complications or allergies to Vitagnus medicine, Soy, or the combination of Vitagnus and Soy occur
Experienced any unfortunate incident while studying
Suffer physical and mental illness while studying
Do not use any type of treatment to relieve symptoms of PMS during the study period
Do not complete the daily symptom registration questionnaire or complete the form incompletely
Do not use the medicine according to the instructions and opinion of the pharmacologist
Do not want to continue taking medicine and cooperate in the plan
Age
From 16 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
In order to guarantee an equal number of study subjects in two groups, random permutation block method is determined using the website www.sealedenvelope.com. In this way, a number of 4-member blocks are created by accident through the above site. For example, the blocks can be as follows: [ABCABC], [BACBAC], [CACBAB], ...
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind so that the researcher and the participants will not know which group each person will be placed in.
Placebo
Not 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
Qureshi Building., University Street., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595199
Approval date
2022-07-19, 1401/04/28
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.055
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
The mean score of severity of physical, mental and total premenstrual syndrome by the premenstrual events calendar form (COPE)
Timepoint
The average symptom severity score at the end of the first and second cycles after the intervention compared to before the intervention in the three groups receiving Vitagnus capsules, Soy and the combination of Vitagnus and Soy
Method of measurement
Premenstrual Events Calendar Questionnaire (COPE)
Secondary outcomes
1
Description
Dysmenorrhea or menstrual pain
Timepoint
The average score of menstrual pain intensity at the end of the first and second cycles after the intervention compared to before the intervention in three groups receiving Vitagnus capsules, Soy and the combination of Vitagnus and Soy
Method of measurement
Visual Pain Scale Questionnaire (VAS)
Intervention groups
1
Description
The first intervention group: 500 mg Vitagnus and soy combined capsule, containing 20 mg dry extract of Vitex agnus-castus and 250 mg Soy powder, once a day after breakfast for 2 consecutive menstrual cycles.
Category
Prevention
2
Description
The second intervention group: Vitagnus 500 mg capsule, containing 40 mg dry extract of Vitex agnus-castus, once a day after breakfast for 2 consecutive menstrual cycles.
Category
Prevention
3
Description
The third intervention group: 500 mg Soy capsule, containing 500 mg soy powder, once a day after breakfast for 2 consecutive menstrual cycles.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hostel of Mashhad University of Medical Sciences
Full name of responsible person
Seid-Ahmad Mousavi-Kakhki
Street address
Bahonar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
+98 51 3882 8299
Phone
+98 51 3882 8299
Email
Partovigolshan69@gmail.com
Web page address
http://www.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayyur Mobarahan
Street address
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences Qureshi., Building., University St
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3882 5523
Email
ghayourM@mums.ac.ir
Grant name
Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
Grant code / Reference number
4010512
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
Roya Partovigolshan
Position
midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Partovigolshan69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Maryam Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 38591511-3
Email
moradim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roya Partovigolshan
Position
Master's degree student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
partovigr992@mums.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
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
Title and more details about the data/document
Publication of research results in the form of scientific article printining
When the data will become available and for how long
data will become available after publication of the
To whom data/document is available
The general public and all researchers
Under which criteria data/document could be used
For use in the treatment of premenstrual syndrome and scientific use based on the article
From where data/document is obtainable
En Dr. Maryam Moradi, Assistant Professor, Mashhad School of Midwifery Nursing, e-mail: moradim@mums.ac.ir
What processes are involved for a request to access data/document
Request to access data through email and request will be assessed by the research team.