Therapeutic Effect of Herbal Infusion on Menometrorrhagia

NCT05406960 | Completed DMC

• 1 other identifier: FMSELMI
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

plants; Traditional herbal Medicine; Tisane

Outcome Measures

Primary Outcomes (2)

• Reduce the menstrual duration in days

  the Pictorial Blood Loss Assessment Chart (PBLAC) the number of bleeding day during menstruation

  180 days

• Reduce the bleeding abundance

  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 Outcomes (5)

• Change From Baseline in Hematocrit (Hct) Concentrations at Treatment Day 90

  180 days

• Change From Baseline in Hemoglobin Concentration at Treatment Day 90

  90 days

• Change From Baseline in Fibrinogen Concentration at Treatment Day 90

  90 days

• Change From Baseline in Prothrombin Time at Treatment Day 90

  90 days

• hange From Baseline in serum Creatinine Time at Treatment Day 90

  90 days

Study Arms (1)

Tea infusion

EXPERIMENTAL

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

Interventions

Tea infusion DIETARY_SUPPLEMENT

Herbal tea infusion will be administrated by the oral route before food

Tea infusion

Eligibility Criteria

• Age: 30 Years - 55 Years
• Gender Eligibility Details: Women suffering from AUB and being candidates for hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculty of Medicine, Sousse: lead
• Centre Hôpital Universitaire Farhat Hached: collaborator

Study Sites (1)

faculty of medicine Sousse

Sousse, 4000, Tunisia

Location

Related Publications (14)

• 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.

  PMID: 21666466 BACKGROUND

• Bone, K., and Mills, S. Principles and practice of phytotherapy: Modern Herbal Medicine. Churchill Livingstone.2nd ed. Londo n: Elsevier. 2013; 9780702052972

  BACKGROUND

• 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.

  PMID: 17218234 BACKGROUND

• 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.

  PMID: 19579942 BACKGROUND

• 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.

  BACKGROUND

• Teri Moser Woo, Marylou Robinson.Pharmaco therapeutics for Advance Practice Nurse Prescribers. Library of Congress. (2016:138-1520.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20397217 BACKGROUND

• 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.

  PMID: 17204526 BACKGROUND

• 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

  BACKGROUND

• Chopra, R.N, Nayar S.L, Chopra, I.C. Glossary of Indian Medicinal Plant, New Delhi. CSIR.1956 .1-330.

  BACKGROUND

• 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.

  PMID: 25268434 BACKGROUND

• 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.

  PMID: 24888316 BACKGROUND

• 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.

  PMID: 18345348 BACKGROUND

MeSH Terms

Conditions

Metrorrhagia; Menorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, dean of faculty

Model Details: 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

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: June 7, 2022
• Study Start: May 10, 2019
• Primary Completion: December 20, 2020
• Study Completion: February 10, 2021
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)