Therapeutic Effect of Herbal Infusion on Menometrorrhagia (HERBALTREAT)

June 4, 2022 updated by: Pr. Hedi Khairi, Faculty of Medicine, Sousse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sousse, Tunisia, 4000
        • faculty of medicine Sousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tea infusion
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
Dietary supplement: Tea infusion
Herbal tea infusion will be administrated by the oral route before food

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce the menstrual duration in days
Time Frame: 180 days
the Pictorial Blood Loss Assessment Chart (PBLAC) the number of bleeding day during menstruation
180 days
Reduce the bleeding abundance
Time Frame: 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.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 90
Time Frame: 180 days
Hematocrit was measured before treatment and after 90 days at the end of treatment
180 days
Change From Baseline in Hemoglobin Concentration at Treatment Day 90
Time Frame: 90 days
Hemoglobin was measured before treatment and after 90 day A positive value indicates an increase in hemoglobin from baseline at treatment day 90
90 days
Change From Baseline in Fibrinogen Concentration at Treatment Day 90
Time Frame: 90 days
Fibrinogen Concentration was measured before treatment and after 90 day
90 days
Change From Baseline in Prothrombin Time at Treatment Day 90
Time Frame: 90 days
Prothrombin Time was measured before treatment and after 90 day
90 days
hange From Baseline in serum Creatinine Time at Treatment Day 90
Time Frame: 90 days
to detect urinary toxicity. conducted at the start of the trial and after the last infusion consumption days 90
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty of Medicine, Sousse

Collaborators

Centre Hôpital Universitaire Farhat Hached

Investigators

  • Study Director: Hedi Khairi, Pr, CHU, Farhat Hched Hospital, Faculty of medicine sousse tunisia 4000 Sousse Tunisia
  • Study Director: Latifa Lassoued, Pr.Ag, CHU Farhat Hached Hospital, Faculty of medicin Sousse,4000,Sousse,Tunisia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2019

Primary Completion (ACTUAL)

December 20, 2020

Study Completion (ACTUAL)

February 10, 2021

Study Registration Dates

First Submitted

December 24, 2021

First Submitted That Met QC Criteria

June 4, 2022

First Posted (ACTUAL)

June 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 4, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMSELMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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