A CLINICAL STUDY TO EVALUATE THE EFFICACY OF PICCHA BASTI AND CONCENTRATED KUTAJA KASHMARI CAPSULE IN ABNORMAL UTERINE BLEEDING W.S.R TO ADENOMYOSIS AND FIBROID UTERUS
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in FIGO classification of uterine bleeding.
研究概览
简要总结
Abnormal uterine bleeding (AUB), particularly in cases associated with adenomyosis and fibroid uterus, significantly impacts women’s quality of life, causing physical, psychological, and social distress. Conventional treatments like hormonal therapy and hysterectomy, while effective, have limitations due to their side effects and invasive nature. This clinical study aims to evaluate the efficacy of Piccha Basti combined with concentrated Kutaja Kashmari capsules in managing AUB with special reference to adenomyosis and fibroid uterus. Thirty participants diagnosed through transvaginal ultrasonography (TVUSG) will undergo a treatment regimen comprising Piccha Basti, an Ayurvedic enema with astringent and hemostatic properties, and Kutaja Kashmari capsules for two months. The intervention seeks to reduce symptoms like excessive menstrual bleeding and pain while improving TVUSG findings. Outcome measures include subjective parameters like bleeding duration and pain intensity and objective parameters such as endometrial thickness and DEERS criteria.This study explores a holistic Ayurvedic approach to mitigate the adverse effects of conventional treatments and improve patient outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- Female
入选标准
- •Fibroids size less than 8cms Subjects aged between 18 to 55 years.
排除标准
- •a)Post menopausal bleeding and patients with traumatic lesion of genital tract.
- •b)Subjects suffering from any systemic disorders like Diabetes mellitus, Hypertension etc.
- •c)Subjects with other cause of Abnormal uterine bleeding such as polyp, malignancy, coagulopathy, ovulatory dysfunction d)Anemia in which HB% is less than 6.5gm%.
结局指标
主要结局
Improvement in FIGO classification of uterine bleeding.
时间窗: Follow up on 30th day and after 60th day. | DURATION OF STUDY: 60 days
Improvement in pictorial blood loss assessment chart.
时间窗: Follow up on 30th day and after 60th day. | DURATION OF STUDY: 60 days
Improvement in TVUSG parameters
时间窗: Follow up on 30th day and after 60th day. | DURATION OF STUDY: 60 days
次要结局
- To obtain an effective medical management in abnormal uterine bleeding.(Reduction in the risk of anaemia and related complications)
研究者
Dr Preethi Hegde
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka India 574118
