The Effect of Myrtus Communis L. fruit syrup in women bleeding

Phase 2

Conditions: hypermenorrhea.
Excessive and frequent menstruation with regular cycle

Registration Number: IRCT201109077511N1

Lead Sponsor: Medical faulty, Shahed University

Brief Summary: Background: Myrtle (Myrtus communis L.) has been used in the Iranian Traditional Medicine as a treatment for abnormal uterine bleeding-menometrorrhagia. The main aim of this study is to evaluate the effect of myrtle fruit syrup on abnormal uterine bleeding-menometrorrhagia. Methods: A randomized, double-blind, placebo-controlled pilot study was conducted on 30 women suffering from abnormal uterine bleeding-menometrorrhagia. Treatment comprised of giving 15 ml oral myrtle syrup daily (5 ml three times a day) for 7 days starting from the onset of bleeding. The myrtle syrup along with placebo was repeated for 3 consecutive menstrual periods. Menstrual duration and number of used pads were recorded by the Pictorial Blood loss Assessment Chart at the end of each menstrual period. The quality of life was also evaluated using the menorrhagia questionnaire. Results: The mean number of bleeding days significantly declined from 10.6 ± 2.7 days to 8.2 ± 1.9 days after 3 months treatment with the syrup (p = 0.01) and consequently the participants in the intervention group used fewer pads after 3 months (16.4 ± 10.7) compared with the number of pads used at the beginning of the treatment (22.7 ± 12.0, p = 0.01). Bleeding days and number of pads used by the participants in the placebo group did not change significantly. Also significant changes of quality of life scores were observed in the intervention group after 3 months compared to the baseline. Conclusion: Myrtle syrup is introduced as a potential remedy for abnormal uterine bleeding-menometrorrhagia. Keywords: Abnormal uterine bleeding-menometrorrhagia, Effrat-e-tams, Iranian traditional medicine, Myrtus communis L, Myrtle, Myrtaceae

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 30

Inclusion Criteria

Patient satisfaction; outpatients aged 20- 55 years with excessive uterine bleeding that have a negative pregnancy test and they are not lactating; Endometrial thickness in ultrasound is normal; Gynecologic examination is normal; The Pap smear is normal; concurrent hormonal therapy, herbal and other medicinal plants are not used; there are no chronic disease like diabetes, lupus and thyroid problems; there is no organic disease such as uterus or ovaries or other malignancies; Intramural fibroids larger than 5 cm sub mucosal or not; Bleeding is more than 7 days and or Course is less than 21 days. Exclusion criteria: use of hormonal drugs in the study; Use of mefenamic acid in the study; Patients who are experiencing possible side effects; Patients who require surgical intervention and have the other; Patients with a personal request to withdraw from the study; bleeding during the study is so severe that emergency action is required.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Menstrual period duration. Timepoint: at the end of each cycle. Method of measurement: Questionnaire.;Intensity of menstrual bleeding. Timepoint: at the end of each cycle. Method of measurement: Questionnaire.;Hemoglobin. Timepoint: before & after the study. Method of measurement: cell counter.

Secondary Outcome Measures