Premenstrual syndrome. Pain and other conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention 1: Salvia officinalis extract, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily. Intervention 2: Placebo, 500 mg capsule oral, 21st day till the 5th day of n
Treatment - Drugs
Placebo
Salvia officinalis extract, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily
Placebo, 500 mg capsule oral, 21st day till the 5th day of next cycle one capsule daily
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: being single; age between 18-35 years old; normal body mass index; regular menstrual cycle (21-35 days), with diagnosed PMS; no physical or psychological ill conditions; not on medication (hormonal, vitamins, herbal, antidepressant, aspirin, or warfarin); no history of allergy to herbal drugs; no sad event occurrence; no surgical operation during the last six months; not being a professional athlete; presence of at least five symptoms based on DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-fourth edition) for PMS diagnosis with confirmed one symptom out of the first four symptoms including (1. Feeling sad, hopeless or selfdeprecating, 2. Feeling tense, anxious, or “on edge”, 3. Marked liability of mood, interspersed with frequent tearfulness, 4. Persistent irritability, anger and increased interpersonal conflicts, 5. Decreased interest in usual activities that may be associated with withdrawal from social relationships); not being depressed based on Beck questionnaire. Those with the above mentioned criteria were entered into the study. An informed written consent was also given by each participant. Exclusion criteria: allergy to drugs; improper use of capsules and developing a significant disease and taking medications during the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of physical symptoms of premenstrual syndrome. Timepoint: Pre intervention, first month after intervention, second month after intervention. Method of measurement: Form a provisional dignosis of premenstrual syndrome from DSM5.;The severity of psychological symptoms of premenstrual syndrome. Timepoint: Pre intervention, first month after intervention, second month after intervention. Method of measurement: Daily form of severity of premenstrual syndrome.;The severity of symptoms of premenstrual syndrome. Timepoint: Pre intervention, first month after intervention, second month after intervention. Method of measurement: Daily form of severity of premenstrual syndrome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: First month after intervention, second month after intervention. Method of measurement: Questionnaire of effects and side effects of medication. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoghayeh Abdnezhad
Medical Sciences University of Shahid Beheshti
Outcome results
None listed