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.
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.
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.
Parallel
Ginger
Drug750 mg
Placebo
Drug750 mg
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.
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.
Covariance analysis ANCOVA
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