Therapeutic Effect of Herbal Infusion on Menometrorrhagia
Condition: Abnormal Uterine Bleeding; Menorrhagia; Postmenopausal; Metrorrhagia; Hysterectomy; Heavy Menstrual Bleeding
MeSH terms: Uterine Hemorrhage; Menorrhagia; Metrorrhagia; Hemorrhage
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Tea infusion
Intervention type(s): Dietary Supplement
Intervention description(s): Herbal tea infusion will be administrated by the oral route before food
Intervention model: Single Group Assignment
Intervention model description: The gynecologist who decided if the participant met the selection criteria or not Participants meeting the selection criteria will be included in the study.
Before starting all the included participants underwent a complete physical examination. Written informed consent will be obtained.
The herbal tea infusion will be self-administrated by participants at home.
Participants will receive training on how to make herbal tea infusions at home.
Participants will be interviewed by the investigator of the study:
To complete a quality-of-life questionnaire to determine the impact of the illness on their daily life.
Pictorial Bleeding Assessment Chart (PBAC): The history of the last menstruation period
Participants will be asked to perform before starting the treatment :
Complete blood count (CBC)
Prothrombin Time (PT)
Prothrombin ratio (INR)
Fibrinogen (FIB) to detect bleeding disorders
serum Creatinine to detect urinary toxicity
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plants; Traditional herbal Medicine; Tisane