Evaluation of the effect of Foeniculum vulgare fruit and Echium amoenum Flower Combination on the severity of Physical and psychological symptoms of premenstrual syndrome

Phase 3

Recruiting

Conditions: Premenstrual Syndrome.
Premenstrual tension syndrome
N94.3

Registration Number: IRCT20200530047600N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Age 18 to 35 years
Regular menstruation for the past 6 months,
Bleeding period 3 to 9 days and two bleeding intervals 24 to 35 days,
Complete the conscious consent form
Get a minimum score of 19 from the PSST questionnaire

Exclusion Criteria

History of mental illness, surgery, estrogen-related cancers, thyroid, liver and kidney disease, diabetes and hypertension
Death of a loved one in the last six months
The use of anti-anxiety and anti-depressant drugs in the last three months,
The use of estrogen and progesterone medications in the last three months,
Taking herbal medicines and vitamin and mineral supplements over the past month,
History of allergy to Echium and fennel
Pregnancy and lactation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of change in the severity of symptoms of premenstrual syndrome. Timepoint: Before the intervention, the first menstrual cycle after the intervention, the second menstrual cycle after the intervention. Method of measurement: Daily Record of Severity of Problems (DRSP).

Secondary Outcome Measures

Name	Time	Method
The relationship between general temperament and the severity of symptoms. Timepoint: At the beginning of the study. Method of measurement: Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ).;Changes in the quality of life in the intervention and control groups. Timepoint: Before and after the intervention. Method of measurement: Short-Form Health Survey questionnaire(SF-36).;Possible side effects. Timepoint: During the intervention. Method of measurement: Patient report.;The relationship between general temperament and the type of symptoms. Timepoint: At the beginning of the study. Method of measurement: Daily Record of Severity of Problems (DRSP), Mojahedi Mizaj Questionnaire(MMQ).