Effect of Saffrons in Premenstrual Syndrome

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2017061233202N2
• Date of registration: 2017-09-08
• Prospective Registration: No
• Primary sponsor: Vice chancellor for research, Sabzevar University of Medical Sciences
• Public title: Effect of Saffrons in Premenstrual Syndrome
• Scientific title: Comparison of the effect of Saffron and Fluoxetine in treatment women that have Premenstrual Syndrome
• Date of first enrolment: 2017-05-22
• Target sample size: 164
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/25675
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study was adouble-blinded study, the researcher, analyst, and recipients were not aware of the contents of the capsule. Only doctor in charge is aware of the contents of the capsule (with the numbered code on the package of the first and second capsule ) .
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Atefeh Asadi
• Affiliation: Sabzevar University of Medical Sciences

• Name: Atefeh Aasadi
• Affiliation: Sabzevar University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: informed consent; Eighteen to forty years; regular Menstrual Periods( 35-21 days); Normal cycle (10-3 day); Physical and Mental health; The absence of anemia in the past three months ; Having one or more Symptoms of Premenstrual Syndrome in 2 consecutive cycles; no Pregnancy intention.
Exclusion criteria: Underlying disease; Taking other drugs
Exclusion criteria:

Age minimum: 18 years
Age maximum: 40 years
Gender: Female

Health Condition(s) or Problem(s) studied

Premenstual Syndrom.
Unspecified condition associated with female genital organs and menstrual cycle

Unspecified condition associated with female genital organs and menstrual cycle

Intervention(s)

Control groups: fluoxetine, capsule 20 mg, oral, once a day from fourteen to twenty-eight day menstrual cycle for two months.

Intervention 1: Intervention group: saffron, self-made capsule 30 mg, oral, once a day from fourteen to twenty-eight day menstrual cycle for two month. Intervention 2: Control groups: fluoxetine, capsule 20 mg, oral, once a day from fourteen to twenty-eight day menstrual cycle for two months.

Intervention group: saffron, self-made capsule 30 mg, oral, once a day from fourteen to twenty-eight day menstrual cycle for two month.

Treatment - Drugs

Primary Outcome(s)

Anexity. Timepoint: From 14 to 28 cycles are recorded on a daily basis. Method of measurement: Test anxiety Beck.

Abdominal Bloat. Timepoint: From 14 to 28 cycles are recorded on a daily basis. Method of measurement: weist size.

Abdominal Pain. Timepoint: From 14 to 28 cycles are recorded on a daily basis. Method of measurement: Vigual Scare.

Deppretion. Timepoint: From 14 to 28 cycles are recorded on a daily basis. Method of measurement: Test Deppretion Beck.

Masstalgia. Timepoint: From 14 to 28 cycles are recorded on a daily basis. Method of measurement: Vigual Scare.

Source(s) of Monetary Support

Vice chancellor for research, Sabzevar University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics committee of Sabzevar University of Medical Sciences