Clinical trial NCT05406960: Therapeutic Effect of Herbal Infusion on Menometrorrhagia
Official title: The Therapeutic Effect of Traditional Herbal Tea Infusion on Abnormal Uterine Bleeding- Menometrorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Menorrhagia; Postmenopausal
Metrorrhagia
Hysterectomy
Heavy Menstrual Bleeding
Keywords: plants
Traditional herbal Medicine
Tisane
Lead sponsor: Faculty of Medicine, Sousse
Sponsor class: OTHER
Collaborators: name: Centre Hôpital Universitaire Farhat Hached
First posted: 2022-06-07
Enrollment: 13
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduce the menstrual duration in days
timeFrame: 180 days
measure: Reduce the bleeding abundance
timeFrame: 180 days
Secondary outcomes:
measure: Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 90
timeFrame: 180 days
measure: Change From Baseline in Hemoglobin Concentration at Treatment Day 90
timeFrame: 90 days
measure: Change From Baseline in Fibrinogen Concentration at Treatment Day 90
timeFrame: 90 days
measure: Change From Baseline in Prothrombin Time at Treatment Day 90
timeFrame: 90 days
measure: hange From Baseline in serum Creatinine Time at Treatment Day 90
timeFrame: 90 days
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: faculty of medicine Sousse
Study officials:
affiliation: CHU, Farhat Hched Hospital, Faculty of medicine sousse tunisia 4000 Sousse Tunisia
name: Hedi Khairi, Pr
role: STUDY_DIRECTOR
affiliation: CHU Farhat Hached Hospital, Faculty of medicin Sousse,4000,Sousse,Tunisia
name: Latifa Lassoued, Pr.Ag
role: STUDY_DIRECTOR
References:
citation: Donnez J, Squifflet J, Donnez O. Minimally invasive gynecologic procedures. Curr Opin Obstet Gynecol. 2011 Aug;23(4):289-95. doi: 10.1097/GCO.0b013e328348a283.
citation: Bone, K., and Mills, S. Principles and practice of phytotherapy: Modern Herbal Medicine. Churchill Livingstone.2nd ed. Londo n: Elsevier. 2013; 9780702052972
citation: Istre O, Langebrekke A, Qvigstad E. Changing hysterectomy technique from open abdominal to laparoscopic: new trend in Oslo, Norway. J Minim Invasive Gynecol. 2007 Jan-Feb;14(1):74-7. doi: 10.1016/j.jmig.2006.08.011.
citation: Jazani NH, Ghasemnejad-Berenji H, Sadegpoor S. Antibacterial effects of Iranian Mentha pulegium essential oil on isolates of Klebsiella sp. Pak J Biol Sci. 2009 Jan 15;12(2):183-5. doi: 10.3923/pjbs.2009.183.185.
citation: Kowalski R, Wawrzykowski J, Zawiślak G.Analysis of essential oils and extracts from Artemisia abrotanum L. and Artemisia dracunculus L. Herba Pol.2007.53: 246-254.
citation: Teri Moser Woo, Marylou Robinson.Pharmaco therapeutics for Advance Practice Nurse Prescribers. Library of Congress. (2016:138-1520.
citation: European Tea Committee (ETC), European Herbal Infusions Association (EHIA).Inventory List of Herbals Considered as Food. 2016 Available at: https://thie-online.eu/files/thie/docs/2019-09-26_PU_THIE_Inventory_List_status_27-06-2019_final.pdf
citation: Sutour S, Bradesi P, Casanova J, Tomi F. Composition and chemical variability of Mentha suaveolens ssp. suaveolens and M. suaveolens ssp. insularis from Corsica. Chem Biodivers. 2010 Apr;7(4):1002-8. doi: 10.1002/cbdv.200900365.
citation: Fraser IS, Critchley HO, Munro MG, Broder M. Can we achieve international agreement on terminologies and definitions used to describe abnormalities of menstrual bleeding? Hum Reprod. 2007 Mar;22(3):635-43. doi: 10.1093/humrep/del478. Epub 2007 Jan 4.
citation: Oueslati, S, Karray-Bouraoui, N, Attia, H. et al. Physiological and antioxidant responses of Mentha pulegium (Pennyroyal) to salt stress. Acta Physiol Plant 32. 2010.289-296. https://doi.org/10.1007/s11738-009-0406-0
citation: Chopra, R.N, Nayar S.L, Chopra, I.C. Glossary of Indian Medicinal Plant, New Delhi. CSIR.1956 .1-330.
citation: Hoffmann TC, Montori VM, Del Mar C. The connection between evidence-based medicine and shared decision making. JAMA. 2014 Oct 1;312(13):1295-6. doi: 10.1001/jama.2014.10186. No abstract available.
citation: Qaraaty M, Kamali SH, Dabaghian FH, Zafarghandi N, Mokaberinejad R, Mobli M, Amin G, Naseri M, Kamalinejad M, Amin M, Ghaseminejad A, HosseiniKhabiri SJ, Talei D. Effect of myrtle fruit syrup on abnormal uterine bleeding: a randomized double-blind, placebo-controlled pilot study. Daru. 2014 Jun 2;22(1):45. doi: 10.1186/2008-2231-22-45.
citation: Kang M, Ragan BG, Park JH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Apr-Jun;43(2):215-21. doi: 10.4085/1062-6050-43.2.215.