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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201509182889N5
Enrollment
92
Registered
2017-01-09
Start date
2015-04-30
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

premenstrual syndrome. premenstrual tention syndrome

Interventions

Intervention 1: Intervention group 1: the auriculotherapy will be executed in 10 weekly sessions during 2 menstruation cycles (except for the 7 days of menstrual bleeding). Each session will be laste
seeds will be pressured by the participant for a whole minute every hour except for the time of sleep. Phone calls will be made for reminding. Intervention 2: Intervantion group 2: They will take Vit
Treatment - Other
Treatment - Drugs
Intervention group 1: the auriculotherapy will be executed in 10 weekly sessions during 2 menstruation cycles (except for the 7 days of menstrual bleeding). Each session will be lasted about 20 minut
seeds will be pressured by the participant for a whole minute every hour except for the time of sleep. Phone calls will be made for reminding.
Intervantion group 2: They will take Vitamin B6 (40 mg) (made by Iran Hormone Company), daily from one week before starting of menstrual bleeding. This group will continue the consumption of B6 during

Sponsors

Isfahan Research Department of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
General health-Depression-Anxiety. Timepoint: preintervention -1 and 2month after intervention. Method of measurement: GHQ(28) and Beck questionairs.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactsharareh koleini

Isfahan University of Medical Sciences

sharareh_Koleini@yahoo.com+98 31 3792 2936

Outcome results

None listed

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