Efficacy of Calcium Dobesilate As an Alternative Method for Treatment of Menorrhagia, Comparison to Tranexamic Acid
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Reduction in Menstrual Blood Loss
研究概览
简要总结
The goal of this clinical trial is to determine if calcium dobesilate is an effective alternative to tranexamic acid for treating menorrhagia in women aged 18 to 39 years. The main questions it aims to answer are:
Does calcium dobesilate reduce menstrual blood loss and improve hemoglobin levels as effectively as tranexamic acid? What side effects and acceptability differences exist between calcium dobesilate and tranexamic acid? Researchers will compare calcium dobesilate to tranexamic acid to see if calcium dobesilate is as effective in reducing heavy menstrual bleeding and improving patient outcomes.
Participants will:
Take calcium dobesilate or tranexamic acid during their menstrual cycle for three consecutive cycles.
Record menstrual blood loss using the Pictorial Blood Loss Assessment Chart (PBAC).
Attend follow-up visits after each menstrual cycle to monitor hemoglobin levels, menstrual symptoms, and any side effects.
详细描述
This randomized controlled trial aims to compare the efficacy and safety of calcium dobesilate and tranexamic acid in treating menorrhagia in women aged 18 to 39 years. Menorrhagia, characterized by heavy menstrual bleeding exceeding 80 mL per cycle, significantly impacts quality of life and may lead to complications such as anemia.
Participants meeting the inclusion criteria will be randomly assigned to one of two groups:
Group A: Participants will receive calcium dobesilate (500 mg capsules), administered orally at a daily dose of 0.5-2 g during each menstrual cycle for three consecutive cycles.
Group B: Participants will receive tranexamic acid (500 mg capsules), administered orally at a dose of two capsules three times daily during each menstrual cycle for three consecutive cycles.
Primary outcomes will include:
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
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 to 39 years
- •Patients with menorrhagia
- •Incidence of breakthrough bleeding while on treatment
- •Patient with heaviness of the bleeding
排除标准
- •Patients with hemoglobin less than 7gm/dl
- •Patient with pelvic pathologies like uterine fibroids, suspected adenomyosis, malignancies of uterus/cervix/ovary/vagina/endometrial hyperplasia with atypia.
- •Patient with medical diseases like liver dysfunction, heart disease, migraine, stroke, renal disease, hypo/hyperthyroidism, platelet disorders or coagulopathy.
- •Patient with previous history of thrombosis; pregnancy, abortion, use of IUCDs or oral contraceptives; lactating women in first 6 months of post-natal period and hypersensitivity to the drug
研究组 & 干预措施
Group A: Patients receiving Calcium Dobesilate (Doxium)
Intervention: Patients in Group A will be administered Calcium Dobesilate (Doxium) capsules.
Dosage: The dose will be 500 mg of Calcium Dobesilate, administered orally at a frequency of three times a day. The total daily dose can range from 1-4 tablets (equivalent to 0.5-2 g/day), starting from the first day of the menstrual cycle and continuing until the bleeding ceases.
干预措施: Calcium dobesilate (Doxium) (Drug)
Group B: Patients receiving Tranexamic Acid
Intervention: Patients in Group B will receive Tranexamic Acid capsules. Dosage: The dose will be 500 mg of Tranexamic Acid, administered orally at a frequency of three times a day. This will continue from the first day of the menstrual cycle until the bleeding stops.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Reduction in Menstrual Blood Loss
时间窗: At the end of the third treatment cycle (each cycle is 28 days).
Menstrual blood loss will be measured using the Pictorial Blood Loss Assessment Chart (PBAC). Participants will record the number and type of sanitary products used (e.g., pads or tampons) and the degree of saturation, along with any clots passed. PBAC scores above 100 are indicative of heavy menstrual bleeding. A reduction in PBAC scores after the third treatment cycle (each cycle lasting 28 days) will be used to determine the effectiveness of the intervention.
次要结局
- Improvement in Hemoglobin Levels(At the end of the third treatment cycle (each cycle is 28 days).)
研究者
Bazgha Naeem
Post Graduate Resident
University of Health Sciences Lahore