Therapeutic Effect of Herbal Infusion on Menometrorrhagia — HERBALTREAT  

Hysterectomy Clinical Trial

Official title: The Therapeutic Effect of Traditional Herbal Tea Infusion on Abnormal Uterine Bleeding- Menometrorrhagia

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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

All details with regard to :

• The effect of the treatment on the menstrual cycle

• Menstruation duration

• Adverse effects

• Bleeding intensity measured using Pictorial Blood Assessment Chart during three consecutive menstrual treatments and the three-month follow-up.

will be collected from participants by phone

Details about the Follow-up:

Allocated to intervention :

Follow-up (Visit 2): Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.

Phone or direct contact one week after treatment Follow-up 3: Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.

Phone or direct contact one week after treatment Follow-up (Visit 4): Phone or direct contact after the end of oral administration (day 3) for clinical response evaluation.

Phone or direct contact one week after treatment VISIT 5 (closing visit)

Statistical Analysis

Data entry and analysis will be performed using ( IBMV SPSS R 20.0). To test for normality and distribution of the variables. A significance level of a p-value of less than 0.05 will be considered Descriptive statistics will be used to examine the characteristics of the study population (means, standard deviation).

Comparison of the biological parameters and scores of PBAC between baseline and the end of treatment will be performed using paired t-test when variables are normally distributed and Wilcoxon signed ranks test, as a non-parametric test when variables are not normally distributed.

Sample size

The sample size will be assessed according to the following formula N = (Zα/2) 2 s2 /d2, where "s" is the standard deviation (SD ).

"d" is the accuracy of the estimate. "Zα/2" is the normal deviate for a two-tailed alternative hypothesis at a level of significance. ;

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Heavy Menstrual Bleeding
• Hemorrhage
• Hysterectomy
• Menorrhagia
• Metrorrhagia
• Uterine Hemorrhage

• NCT number: NCT05406960
• Study type: Interventional
• Source: Faculty of Medicine, Sousse
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Completion date: February 10, 2021