Effect of Ginger on Heavy Menstrual Bleeding in Women With Coagulation Disorders
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 74
研究概览
简要总结
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.
详细描述
INTRODUCTION: CURRENT STATUS AND JUSTIFICATION FOR RESEARCH Heavy menstrual bleeding is one of the common causes of gynecological health problems in women of childbearing age who suffer from coagulation disorders.
Heavy menstrual bleeding is bleeding of endometrial origin that occurs in the first phase of the female hormonal cycle during menstruation. It is considered heavy when it exceeds 80 ml in a menstrual cycle.
Up to 25% of gynecological consultations in hospitals are due to heavy menstrual bleeding in both women with and without coagulation problems. It is known that despite this, there is underdiagnosis, as women often do not seek medical advice for this problem.
The quality of life of women with heavy menstrual bleeding is clearly impaired, as it can interfere with their lifestyles, work performance, daily activities, and even social commitments. It is not uncommon for these women to develop anemia due to excessive blood loss and iron deficiency.
The factors involved in heavy menstrual bleeding are known to be higher levels of fibrinolysis, or the dissolution of clots that prevent bleeding from stopping, and an imbalance in prostaglandin levels, as the uterus tends to contain higher levels of prostaglandin receptors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Ginger
干预措施: Ginger (Drug)
研究者
Rosa María Cárdaba García
Doctorate in Feminist and Gender Studies
University of Valladolid