Effect of Chandrakalarasa in Abnormal Uterine Bleeding due to Ovulatory Dysfunction
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Chandrakala rasa in reducing the amount of bleeding in AUB O assessed by PBAC score and in reducing duration of bleeding
研究概览
简要总结
Abnormal uterine bleeding is a condition where there is deviations from normal terms of volume, duration, regularity, or frequency of uterine bleeding, constituting nearly 30% of all gynecological complaints. In 2011, FIGO introduced PALM-COEIN classification system to categorize the etiological factors of abnormal uterine bleeding.Among the various etiological factors outlined in this classification, ovulatory dysfunction is a significant contributor to abnormal uterine bleeding.In Ayurveda a similar condition is seen, named “Asrigdhara” characterized by excessive or prolonged vaginal bleeding.The treatment principles of rakthapitta,raktha atisara,raktha arshas,guhyaroga and garbhasrava can be adopted. This study focuses on investigating the effect of Chandrakala rasa, a herbomineral formulation indicated for managing "rakthapitta" and "pradara,"in AUB-O. Chandrakala rasa, mentioned in the "mutrakricha prakarana" of Bhaisajya Ratnavali, contains ingredients which are mainly vatapittasamana,that helps in addressing abnormal uterine bleeding. The study design is an Interventional pre- and post study ,with sample size 26 including subjects aged 18-45 years diagnosed with abnormal uterine bleeding due to ovulatory dysfunction, coming under specific inclusion and exclusion criteria. Data collection will be done by clinical observation through case proforma and relevant investigations. Medicines are sourced from GMP-certified pharmacy and administered in a prescribed manner.The medicine is prescribed in the following manner, that is 250mg of Chandrakala rasa will be given twice daily after food, starting from the fourth day of menstrual bleeding until cessation of bleeding or for a period of maximum 10 days. The duration of the clinical trial will be 3 consecutive menstrual cycle. Assessment will be done on the basis of Pictorial Blood loss Assessment Chart score after each bleeding phase when bleeding stops or 5th day or 10th day of medication . Vitals will be checked on each visit. The results will be analysed statistically with appropriate tests and the conclusions will be derived.
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
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women who are willing to give written consent among the age group of 18 to 45 years having the complaint of ovulatory dysfunction by excluding other structural and functional causes of AUB by USG abdomen and pelvis, prolonged bleeding that is for a period of more than 7 days and excessive menstrual bleeding for blood loss of more than 80 ml or changing more than 3 pads completely soaked per day for the past 3 menstrual cycle.
排除标准
- •Blood haemoglobin level less than 7gm percentage, pregnant and lactating mothers,vaginal bleeding due to inherited bleeding disorders,vaginal bleeding after menopause,bleeding in patients taking hormonal therapy,associated with IUCD or oral contraceptive pills,known case of systemic diseases like uncontrolled diabetic mellitus,hypertension,liver dysfunction.
结局指标
主要结局
To evaluate the effect of Chandrakala rasa in reducing the amount of bleeding in AUB O assessed by PBAC score and in reducing duration of bleeding
时间窗: after 3 consecutive menstrual cycle
次要结局
- to evaluate the effect of Chandrakala rasa on blood haemoglobin level(after 3 consecutive menstrual cycles)
研究者
Maya S Kumar
Government Ayurveda College Tripunithura