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Evaluation the effect of salvia officinalis on premenstrual syndrome

Phase 2
Conditions
Premenstrual syndrome.
Pain and other conditions associated with female genital organs and menstrual cycle
Registration Number
IRCT201508268801N20
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
90
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

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Side effects. Timepoint: First month after intervention, second month after intervention. Method of measurement: Questionnaire of effects and side effects of medication.
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