Comparative Assessment of the Efficacy and Safety of Venoactive Drug Treatment of Pelvic Venous Disorders
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Severety of the chronic pelvic pain
研究概览
简要总结
Venoactive drug (VAD) therapy is one of the most effective methods of treating chronic venous diseases (CVD). Numerous studies have proven its high efficacy in relieving symptoms of CVD, such as leg pain and swelling, leg heaviness and fatigue. Pelvic venous disorders (PeVDs) represent a group of pathological conditions including varicose veins of the pelvis and vulva, and compression stenoses of the left renal and common iliac veins. Although PeVDs are associated with venous lesions of the pelvis and retroperitoneum and have specific clinical manifestations, they are one of the forms of CVD and constitute a separate cohort. A number of studies on the VAD usage in PeVD indicate the wide possibilities of this type of treatment in eliminating chronic pelvic pain (CPP), the most dramatic symptom of PeVD, which is the main cause of disability and decreased quality of life, social and daily activity in women with PeVD. Currently, a variety of VADs are presented on the pharmaceutical market, which, according to the product labels, provide effects not only on the venous outflow from the lower extremities, but also on venous hemodynamics in the pelvis. At the same time, a literature analysis shows that micronized purified flavonoid fraction (MPFF) has the greatest evidence base obtained in the efficacy and safety studies of VADs in PeVD. Nevertheless, patients are rarely interested in the scientific dossier of drugs, and in the real practice the patients with PeVD and CPP most often ask: "What is the best drug to use for the CPP relief?" This is quite understandable, as it is CPP in PeVD that results not only in disability, but also in family conflicts, psycho-emotional stress and depressive states. In this regard, patients seek to get rid of pain as soon as possible and strive to use the most effective drug. An extensive scientific base of comparative studies on the use of various VADs in patients with CVD and PeVD has been accumulated to date. However, the literature is lack of any data on the comparative efficacy and safety of VADs in the treatment of patients with PeVD. This, in turn, makes not possible for doctors and patients to choose the optimal and most effective drug based on the objective research data. All the above has predetermined the purpose of the planned study as evaluating the efficacy and safety of different VADs in the treatment of female patients with PeVD.
详细描述
Study objectives:
- To evaluate the efficacy of diosmin-containing VADs in the CPP relief in female patients with PeVD;
- To evaluate the safety (by the number of side effects and adverse events) of diosmin-containing VADs in female patients with PeVD;
- To compare the efficacy and safety of treatment with different diosmin-containing VADs;
- To evaluate the patients' adherence to the different recommended diosmin-containing VADs in female patients with PeVD.
Patients and methods: A total of 150 female patients of reproductive age with symptomatic PeVD and without any other diseases accompanied by CPP are planned for the inclusion in the study.
Clinical study: All patients will be examined by an investigating physician. Complaints, medical history, and physical examination results will be recorded in the individual patient's case report form (CRF). The severity of CPP will be assessed using a 10-score visual analogue scale (VAS) before treatment and then weekly for 2 months of treatment with VAD.
Diagnostic methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Sealed envelope principle
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
- •Age from 18 to 45 years;
- •The presence of PeVD symptoms (CPP, dyspareunia, discomfort in the hypogastrium, dysuria, vulvar varicose veins);
- •The presence of pelvic varicose veins with reflux in them, according to DUS;
- •Pelvic venous reflux (PVR) lasting for greater than 1 s, according to DUS;
- •Isolated dilation and reflux in the parametrial and uterine veins, according to DUS;
- •Absence of competing abnormalities, accompanied by CPP.
排除标准
- •Asymptomatic form of the disease;
- •Menopause;
- •Pregnancy;
- •Post-thrombotic disease;
- •Neoplasms;
- •Competing diseases with CPP;
- •Known hypersensitivity to any of the components of the used VAD.
研究组 & 干预措施
Group 1
Group will include 50 patients, which will be treated by MPFF 1000 mg once daily for 2 months
干预措施: Micronized purified flavonoid fraction (Drug)
Group 2
Group will include 50 patients which will be treated by Diosmin 600 mg once daily for 2 months
干预措施: Diosmin 600 (Drug)
Group 3
Group will include 50 patients which will be treated by combination Hespiridin+Diosmin 1000 mg once daily for 2 months
干预措施: Hesperidin+Diosmin combination 1000 (Drug)
结局指标
主要结局
Severety of the chronic pelvic pain
时间窗: Every weekly until 8 weeks
Evaluation of the efficacy of venoactive drug treatment on chronic pelvic pain by using visual analogue scale
次要结局
- Side and adverse effects(during the treatment until 8 weeks)
研究者
Sergey Gavrilov, MD, PhD
Professor
Pirogov Russian National Research Medical University
