Clinical Trial

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

Study acronym: GINGER-BLEED
Not Yet Recruiting Early Phase 1
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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.
Trial Details
NCT Number NCT07595640
Lead Sponsor University of Valladolid
Conditions Women With Coagulation Disorders
Enrollment 74 participants
Start Date 2028-02-01
Primary Completion 2029-01-02 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-19