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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200530047600N1

Enrollment

Registered

2020-07-18

Start date

2021-09-23

Completion date

Unknown

Last updated

2021-11-01

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: Intervention group: The test group received oral capsules containing Echium and fennel at a dose of 2 grams of Echium and 1 gram of fennel fruit (Ground and granulated) during the day

Eligibility

Sex/Gender

Female

Age

18 Years to 35 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSimin Sadat Motevalli Haghi

Mashhad University of Medical Sciences

motevalihs961@mums.ac.ir+98 51 3891 0394

Outcome results

None listed

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