Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect on pelvic pain by visual analogue scale (VAS)
研究概览
简要总结
Endometriosis is a chronic gynecological disease characterized by sustained painful symptoms that are responsible for a decline in the quality of life of sufferers. Endometriosis is fairly common, affecting an estimated 10%-15% of women and girls, usually during their reproductive years. Based on these rough estimates, the latest epidemiological studies suggest that over 200 million women are might be affected who may commonly have infertility problems. Additionally, endometriosis is a major factor increasing by 33-66% risk of ovarian cancer. V-Endo is a tableted preparation derived from hydrolyzed, heat-inactivated, pooled blood of women with endometriosis. When taken orally it is postulated to cause the immune tolerance and anti-inflammatory effect as a result.
详细描述
Anatomically endometriosis is characterized by the presence of endometrial-type mucosa outside the uterine cavity. This tissue proliferates and causes chronic inflammation resulting in pain and excessive menstrual bleeding. Conventional treatment includes surgical and pharmacological therapy aiming at reducing painful symptoms. However, there is an unmet need in finding optimally safe and effective treatment. This study aimed to evaluate the effect of V-Endo on pain levels in women with endometriosis, focusing on reducing inflammation by immunotherapeutic intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age between 18 and 50 years
- •pain visual analog scale (VAS) score over 4 (visual linear scale from 0 to 10)
- •confirmation of endometriosis by laparoscopy
- •no drugs used at least for one month prior to enrollment, i.e., estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists as well as nonsteroidal anti-inflammatory drugs (NSAIDs)
排除标准
- •presence of other associated diseases such as malignancies
- •concomitant use of hormonal drugs
- •menopause
- •pregnancy
- •surgery for endometriosis within the last month prior to study entry
- •unable or unwilling to give written consent patients
- •adverse reaction or hypersensitivity to active substance or excipients of V-Endo
研究组 & 干预措施
One arm open label V-Endo recepients
This is single arm open label trial wherein active drug is V-Endo
干预措施: V-Endo (Biological)
结局指标
主要结局
Effect on pelvic pain by visual analogue scale (VAS)
时间窗: 2 months
The pain VAS is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
次要结局
- Effect of V-Endo on complete blood count (CBC)(2 months)
- Changes induced By V-Endo on life quality(2 months)
- Effect of V-Endo liver and kidney biochemistry parameters(2 months)