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IRCT201601143706N28 IRCT 2016-02-29 Vice chancellor for research, Tabriz University of Medical Sciences The effect of ethanol extract of Iranian borage on menstrual pain intensity and quality of life enjoyment and satisfaction of students The effect of ethanol extract of Iranian borage (Echium amoenum) on pain intensity and quality of life enjoyment and satisfaction of students with primary dysmenorrhea: a randomized controlled trial 2016-03-07 anticipated 70 Complete https://irct.ir/trial/3818 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2-3 primary dysmenorrhea. Intervention 1: Intervention group: taking capsules containing 500 mg Iranian borage (Echium amoenum) every 12 hours, from onset of menstrual pain for 72 hours or until the pain relief for three consecutive cycles. Intervention 2: Control group: taking placebo capsules every 12 hours, from onset of menstrual pain for 72 hours or until the pain relief for three consecutive cycles.
public Farideh Quick
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
Tabriz Iran (Islamic Republic of) +98 87 3552 2646 Faridequick@gmail.com Midwifery Department, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh-Charandabi
Faculty of Nursing & Midwifery, South Shariati Street, Tabriz, Postal Code 5138947977, PO Box 347-51745
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3477 2699 alizades@tbzmed.ac.ir; mhammadalizadehs@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1) single; 2) age between 18 and 30 years; 3) regular menstrual periods with interval of 21 to 35 days; 4) moderate to severe menstrual pain (above 4.4 mm in 10 cm VAS) over the past 6 months; 5) lack of heavy menstrual bleeding Exclusion criteria: 1) any sensitivity to herbal medicines; 2) smoking or alcohol drinking; 3) any known chronic diseases; 4) no easy access to telephone line for the follow-ups 18 years 30 years Female N94.4 primary dysmenorrhea Treatment - Drugs Treatment - Drugs Intervention group: taking capsules containing 500 mg Iranian borage (Echium amoenum) every 12 hours, from onset of menstrual pain for 72 hours or until the pain relief for three consecutive cycles Control group: taking placebo capsules every 12 hours, from onset of menstrual pain for 72 hours or until the pain relief for three consecutive cycles Quality of Life Enjoyment and Satisfaction. Timepoint: 1) one cycle before intervention 2) The third cycle after intervention. Method of measurement: Quality of Life Enjoyment and Satisfaction questionnaire. Number of Gelofen used. Timepoint: 1) one cycle before intervention 2) The first , second and third cycles after intervention. Method of measurement: Visual analogue scale (VAS) for pain. Menstural pain intensity. Timepoint: 1) one cycle before intervention 2) The first, second and third cycles after intervention. Method of measurement: Visual Analog scale ((VASŁ¬0-10). Menstural Symptom Severity. Timepoint: 1) one cycle before intervention 2) The first cycle, the second and third after intervention. Method of measurement: Symptom Severity Scale. Menstrual blood loss. Timepoint: 1) one cycle before intervention 2) The first cycle, second and third cycles after intervention. Method of measurement: Chart Higham. Side effects. Timepoint: The first cycle, the second and third after intervention. Method of measurement: Self report on a diary. Satisfaction with treatment. Timepoint: The first cycle, the second and third after intervention. Method of measurement: self report- one likert question. Vice chancellor for research, Tabriz University of Medical Sciences Approved 2016-01-04 Ethics Committee of Tabriz University of Medical Sciences Research Deputy, 3rd Floor, Centeral Building No 2 , Tabriz University of Medical Sciences, Golgasht st., Tabriz Tabriz Iran (Islamic Republic of)