Effect of Ginger on Heavy Menstrual Bleeding in Women With Coagulation Disorders

Summary

The GINGER-BLEED study is a randomized, double-blind, placebo-controlled clinical trial evaluating the effect of ginger powder on heavy menstrual bleeding in women with coagulopathies. This type of bleeding, defined as a loss of more than 80 ml per cycle, significantly affects women's quality of life, causing anemia, pain, and social limitations. Although conventional treatments exist, they can cause adverse effects, especially in women with coagulation disorders. The hypothesis is that administering 750 mg of ginger daily for six months can reduce menstrual bleeding. The main objective is to analyze this effect, while specific objectives include evaluating changes in coagulation parameters and prostaglandin levels. The study will be conducted between March 2028 and January 2029 at the University of Valladolid. Seventy-four women with coagulopathies, selected after a gynecological evaluation, ultrasound, and blood tests, will participate. They will be divided into two groups: one will receive ginger capsules and the other a placebo (Stevia) during the first three days of each menstrual cycle for six consecutive cycles. The PBAT tool will be used to estimate bleeding, and statistical analyses will be performed using SPSS v29. Variables such as adverse effects, treatment adherence, and clinical parameters will be considered. The study complies with current ethical standards, including the Declaration of Helsinki and Spanish data protection legislation. The results will be disseminated in scientific journals and patient associations, proposing improvements in public health policies.

Timeline

Start

2028-02-01

Primary completion

2029-01-02

Completion

2029-07-31

Publications

• Background ACOG. (2020). Management of abnormal uterine bleeding in reproductive-aged women. American College of Obstetricians and Gynecologists. Ali, B. H., et al. (2021). Pharmacological and therapeutic properties of ginger: A review. Phytotherapy Research, 35(12), 7113-7132. https://doi.org/10.1002/ptr.7200 Azimi, P., et al. (2020). Effect of ginger on primary dysmenorrhea: A systematic review. Complementary Therapies in Medicine, 48, 102288. https://doi.org/10.1016/j.ctim.2019.102288 Bahrami, A., et al. (2020). Herbal medicines for menstrual disorders: A systematic review. Phytotherapy Research, 34(8), 1899-1911. https://doi.org/10.1002/ptr.6663 Bode, A. M., & Dong, Z. (2020). The amazing and mighty ginger. Nutrients, 12(1), 157. https://doi.org/10.3390/nu12010157 Borzutzky, C., & Jaffray, J. (2020). Bleeding disorders in adolescents with heavy menstrual bleeding. Journal of Pediatric and Adolescent Gynecology, 33(3), 249-255. https://doi.org/10.1016/j.jpag.2019.12.007 Camaschella, C. (2021). Iron deficiency anemia. New England Journal of Medicine, 384(19), 1832-1843. https://doi.org/10.1056/NEJMra1401038 Daily, J. W., et al. (2020). Efficacy of ginger for nausea and vomiting: A meta-analysis. Journal of the Academy of Nutrition and Dietetics, 120(3), 469-484. https://doi.org/10.1016/j.jand.2019.10.015 Fernández-Parra, J., Álvarez-López, C., & Martínez-Morales, S. (2020). Actualización sobre el sangrado menstrual abundante. Progresos de Obstetricia y Ginecología, 63(2), 68-80. https://doi.org/10.20960/jpog.00048 Goyal, M., et al. (2021). Herbal remedies in gynecology: Evidence and mechanisms. Journal of Herbal Medicine, 27, 100425. https://doi.org/10.1016/j.hermed.2021.100425 Higham, J., & O'Brien, S. (2021). Heavy menstrual bleeding: Assessment and management. BMJ, 372, n46. https://doi.org/10.1136/bmj.n46 James, A. H. (2020). Heavy menstrual bleeding: Work-up and management. Hematology/Oncology Clinics of North America, 34(3), 427-438. https://doi.org/10.1016/j.hoc.2020

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