Therapeutic Effect of Herbal Infusion on Menometrorrhagia (HERBALTREAT)

Faculty of Medicine, Sousse

Status: Completed

Conditions: Metrorrhagia; Menorrhagia; Postmenopausal; Hysterectomy; Abnormal Uterine Bleeding; Heavy Menstrual Bleeding

Treatments: Dietary Supplement: Tea infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05406960

FMSELMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Tea infusion

Experimental group

Description:

The aerial parts of each plant were dried, then, they were powdered in a rotating knife grinder. The herbs were taken as tea infusion by the oral route. the powder of the mixture was added to 100 ml of boiling water and the tea infusion was taken three times a day for three consecutive days and it was repeated for three consecutive months

Treatment:

Dietary Supplement: Tea infusion