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

NCT07595640 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: PI-25-537- O
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Women With Coagulation Disorders

Keywords

Ginger (Zingiber officinale); Coagulation disorders; Women; Heavy menstrual bleeding

Outcome Measures

Primary Outcomes (2)

• Parametric or non-parametric tests

  Coagulation parameters will be measured via blood analysis. Adverse effects will be assessed using the CTCAE (Common Terminology Criteria for Adverse Events) criteria. Treatment adherence will be assessed using the Morisky-Green Test. For coagulation parameters, pre-post intragroup comparisons will be performed using the paired t-test or the Wilcoxon signed-rank test; and for intergroup comparisons (pre-post change), the independent t-test or the Mann-Whitney U test will be used. For adverse effects, the chi-square test or Fisher's exact test will be used, and for treatment adherence, the Student's t-test or the Mann-Whitney U test will be used. In all cases, effect sizes will be included using Cohen's d or partial η².

  6 months

• Parametric or non-parametric tests

  The PBAT scale will be used to determine the type of menstrual bleeding, and a personal interview will be conducted for the remaining variables. Quantitative variables will be described by mean and standard deviation, and qualitative variables by frequency and percentage. Statistical analysis will depend on the results of the Kolmogoronov-Smirnov normality test. If normality is not established, analyses will be performed using the Chi-square test, Student's t-test, and ANOVA. In all cases, the effect size will be determined.

  6 months

Secondary Outcomes (1)

• Covariance analysis ANCOVA

  6 months

Study Arms (2)

Ginger

EXPERIMENTAL

Drug: Ginger

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ginger DRUG

750 mg

Ginger

Placebo DRUG

750 mg

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of childbearing age with coagulopathies, -Regular menstrual cycles, -heavy menstrual bleeding (demonstrated by recording 3 menstrual cycles), -who voluntarily wish to participate in the study.

You may not qualify if:

• Women with coagulopathy who have a gynecological disease such as endometriosis, -who are taking any type of hormonal treatment including contraception, -who take nonsteroidal anti-inflammatory drugs during their menstruation, -who have active vaginal infections or pelvic inflammatory disease, -who are overweight (BMI\>25) or underweight (BMI\<25), -who lack the cognitive ability to understand the menstrual cycle and the instructions to follow, -who are allergic to ginger and/or Stevia.

Sponsors & Collaborators

• University of Valladolid: lead

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders; Menorrhagia

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; 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

Central Study Contacts

Rosa M Cárdaba-García, PhD

CONTACT

+34657106213; rosamaria.cardaba@uva.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate in Feminist and Gender Studies

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): February 1, 2028
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share