[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638603":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":26,"locations":11,"responsibleParty":32,"collaborators":11,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":11,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":11},{"fullName":5,"class":6},"University of Valladolid","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ginger","EXPERIMENTAL",null,[13],"Drug: Ginger",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","750 mg",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],[27],{"name":28,"role":29,"phone":30,"phoneExt":11,"email":31},"Rosa M Cárdaba-García, PhD","CONTACT","+34657106213","rosamaria.cardaba@uva.es",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Rosa María Cárdaba García","Doctorate in Feminist and Gender Studies","100638603","early-phase-1-effect-of-ginger-on-heavy-menstrual-bleeding-in-women-with-coagulation-disorders-100638603",false,"NCT07595640","Effect of Ginger on Heavy Menstrual Bleeding in Women With Coagulation Disorders","GINGER-BLEED","Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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\\\u003C25), -who lack the cognitive ability to understand the menstrual cycle and the instructions to follow, -who are allergic to ginger and\u002For Stevia.","FEMALE","18 Years","45 Years",{"count":47,"type":48},74,"ESTIMATED","INTERVENTIONAL",[51],"EARLY_PHASE1","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.\n\nThe 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.\n\nThe 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.\n\nThe 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.",[54],"Women With Coagulation Disorders",[56,57,58,59],"Ginger (Zingiber officinale)","Coagulation disorders","Women","Heavy menstrual bleeding","NOT_YET_RECRUITING","2026-05-14",{"date":63,"type":64},"2026-05-19","ACTUAL",{"date":66,"type":48},"2028-02-01",{"date":68,"type":48},"2029-07-31",{"name":5,"class":6}]