Efficacy of Gulmahar Kashaya and Vaitarana Basti in the management of Endometriosis - An Exploratory Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in endometriotic cyst size in USG (pelvis) findings.
研究概览
简要总结
This clinical trial is being conducted to evaluate the effect of Gulmahar Kashaya and Vaitarana Basti in the management of endometriosis.
Endometriosis is a condition where tissue similar to the uterine lining grows outside the uterus, often causing pain and infertility.
The study will include female patients between 20–40 years of age with ultrasonography-confirmed endometriotic cysts less than 5 cm in size.
The intervention involves administration of Gulmahar Kashaya orally and Vaitarana Basti as part of Yoga Basti procedure.
The main outcome of the study will be reduction in cyst size as seen on ultrasonography. Secondary outcomes will include improvement in pain and quality of life.
This study will help to explore safe and effective Ayurvedic management options for endometriosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •USG confirmed cases of endometriotic cyst less than 5 cm.
- •CA-125 less than 200 U per ml
- •Female patients between the age of 20-40 years diagnosed with endometriosis, willing to participate.
- •Patients presenting with any of the complaint of pelvic pain, dysmenorrhea, dysuria, dyspareunia, dyschezia and irregular menstrual cycles along with endometriotic cyst in USG.
- •Those patients who are eligible for Basti karma.
排除标准
- •Patients with malignancy of genital tract.
- •Patients of chronic diseases like uncontrolled hypertension and diabetes mellitus.
- •Pregnant or lactating women.
- •Patients on hormonal therapy.
- •Those patients who are not eligible for Basti karma.
结局指标
主要结局
Reduction in endometriotic cyst size in USG (pelvis) findings.
时间窗: Baseline and one month after completion of three cycles
次要结局
- Decrease in severity of pain, symptoms of dysmenorrhea, dyspareunia, dysuria, and dyschezia, enhancement of menstrual regularity, and an overall improvement in Quality of Life.(Baseline, after each cycle of procedure and one month after completion of three cycles)
研究者
Dr Sadia Kausar
All India Institute of Ayurveda