The Therapeutic Effect of Traditional Herbal Tea Infusion on Abnormal Uterine Bleeding- Menometrorrhagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Reduce the menstrual duration in days
研究概览
简要总结
This is an interventional, non-randomized, controlled, pilot study that explores a new approach to treat, Abnormal uterine bleeding-menometrorrhagia in women, being candidates for hysterectomy, based on tea infusion consumption of a mixture of two plants.
详细描述
Menometrorrhagia is excessive uterine bleeding resulting from a combination of two different conditions, namely menorrhagia, which is heavy bleeding during the menstrual period, and metrorrhagia, when the period lasts more than seven days or when uterine bleeding exists between periods. It is defined as abnormal uterine bleeding (AUB) and it is a worldwide health problem affecting 11 to 13% of the general female population in the reproductive age and increasing up to 24% in women aged 40-50 years. Conventional treatment of menometrorrhagia consists of symptomatic treatment including tranexamic acid and levonorgestrel intrauterine device. If the first-line medication fails to treat women with AUB, surgical treatment such as a hysterectomy could be necessary. However, both medical treatments and surgical procedures have different side effects, including gastrointestinal symptoms, liver disease, obesity, and thromboembolic diseases. Moreover, the hypoestrogenic state of these therapies can also lead to rapid bone demineralization and menopausal symptoms, such as vaginal dryness and hot flushes, having a negative effect on women's quality of life. Thus, because of these serious side effects, it seems logical to investigate other available sources. Such problems may be beyond the scope of herbal treatment.
Mentha pulegium is a perennial plant from the Lamiaceae family, also known as Pennyroyal, and is used in pharmaceutical and agro-alimentary industries. Artemisia abrotanum L, commonly known as Southernwood, is a small bushy shrub with small, feathery, narrow, and grey-green leaves. The genus belongs to the Asteraceae family.
A mixture of these two herbs is known as a strong emmenagogue.
Data collection:
The plants used in this study were collected through an ethnobotanical survey. The data on the plants' studies were collected through an internet search in: Medicinal plants mentioned in Canon www., www. Science Direct, www.pubmed.com. , www. Scopus, www.wiley.com, www. Google scholar, www. web of science, books in phytotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women failed first-line intervention to stop bleeding and planned for hysterectomy
- •Women between (30-50 years)
- •Able to understand and provide informed consent to participate in the study.
- •Not pregnant or lactating
- •Having menstrual period more than 7 days with uterine bleeding at irregular intervals.
排除标准
- •Participants with at least one of the following criteria will not be included in the trial:
- •Chronic disease with long-term treatment (i.e. asthma, cardiovascular disorders..)
- •woman taking any standard medications for abnormal uterine bleeding
- •Women who have a history of gastrointestinal bleeding or ulcer
- •Women who have abnormal kidney function
- •Participants with increasing menstrual bleeding during the treatment requires surgical emergency procedures.
- •Those refusing the instructions or participating in other clinical trials.
- •Participant take other herbal treatment
- •- Age less than 18 years
- •- Healthy Volunteers
- •women with ovarian tumours
结局指标
主要结局
Reduce the menstrual duration in days
时间窗: 180 days
the Pictorial Blood Loss Assessment Chart (PBLAC) the number of bleeding day during menstruation
Reduce the bleeding abundance
时间窗: 180 days
bleeding abundance will be measured by the Pictorial Blood Loss Assessment Chart (PBLAC) The total score is calculated by adding up the sum of all scores for the sanitary pads used in the menstrual cycle. : 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with bleeding abundance, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea or the absence of menstruation.
次要结局
- Change From Baseline in Fibrinogen Concentration at Treatment Day 90(90 days)
- Change From Baseline in Hemoglobin Concentration at Treatment Day 90(90 days)
- Change From Baseline in Prothrombin Time at Treatment Day 90(90 days)
- Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 90(180 days)
- hange From Baseline in serum Creatinine Time at Treatment Day 90(90 days)
研究者
Pr. Hedi Khairi
Professor, dean of faculty
Faculty of Medicine, Sousse