Comparison of the effect of Vitagnus capsules, Soy and the combination of Vitagnus and Soy in students with premenstrual syndrome

Phase 2

Recruiting

• Conditions: N94.3; Premenstrual syndrome.; Premenstrual tension syndrome

• Registration Number: IRCT20220720055514N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).