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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201601143706N28
Enrollment
70
Registered
2016-02-29
Start date
2016-03-07
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

primary dysmenorrhea. primary dysmenorrhea

Interventions

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 conse
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

Sponsors

Vice chancellor for research, Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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 ((VAS?0-10).

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarideh Quick

Midwifery Department, Nursing & Midwifery Faculty, Tabriz University of Medical Sciences

Faridequick@gmail.com+98 87 3552 2646

Outcome results

None listed

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