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Comparing the effect of auriculotherapy and vitamin B6 on the symptoms of premenstrual syndrome

Phase 3
Conditions
premenstrual syndrome.
premenstrual tention syndrome
Registration Number
IRCT201509182889N5
Lead Sponsor
Isfahan Research Department of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
92
Inclusion Criteria

18 to 35 year old; having regular menstruation cycles with equal intervals (22 to 35 days); having 5 signs of pms in last 2 months; normal BMI ; not having a history of psychological or chronic physical diseases and depression; Not having a history of using anti-depressant; sedatives and hormonal drugs and also drugs that have interactions with vitamin B6 and not having any kind of mass, infection or scar on the external ear .

Exclusion criteria: Occurrence of any undesirable incidence or death; not presenting all the auriculotherapy sessions correctly and completely (more than 2 consecutive absences);not pressuring the seeds in the auriculotherapy group and not completing the table of symptoms’ severity recordings would cause the participants to be excluded.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Premenstrual syndrome(edema, low back pain,low abdominal pain,mastalgia,..). Timepoint: Before of intervention, 1,2,month after intervention. Method of measurement: DSM-IV questionnair.
Secondary Outcome Measures
NameTimeMethod
General health-Depression-Anxiety. Timepoint: preintervention -1 and 2month after intervention. Method of measurement: GHQ(28) and Beck questionairs.
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