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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220720055514N1
Enrollment
108
Registered
2022-08-30
Start date
2022-09-06
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premenstrual syndrome. Premenstrual tension syndrome

Interventions

Intervention 1: 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 conse

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
16 Years to 45 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Partovigolshan

Mashhad University of Medical Sciences

Partovigolshan69@gmail.com+98 51 3859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026