COMBINED EFFECTIVENESS OF SATAVARI GOKSHURA KSHEERAPAKA AND TRIPHALA GUGGULU IN FIBROID WITH HEAVY UTERINE BLEEDING
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in bleeding due to uterine fibroid
研究概览
简要总结
Uterine fibroids otherwise known as leiomyoma is the non cancerous growth commonly seen in women in the childbearing age. They exhibit wide range of symptoms like dysmenorrhea, pressure symptoms, menorrhagia, metrorrhagia, low back ache etc. However menorrhagia and metrorrhagia is a major burden. The exact correlation of uterine fibroids are not available in our classics and it may be correlated to garbhasayagata mamsagranthi which is caused by tridosa mainly vata and kapha along with vitiated mamsa, rakta and medha. When they are present in garbhasaya it increases the surface are of the endometrial tissue resulting in heavy beeding. The menorrhagia and metrorrhagia which are commonly seen in fibroids and comes with heavy uterine bleeding can be critically reviewed in the context of asrgdara with predominance of rakta and pitta. Hence the treatment protocol befitting the samprarpthi vighatana of asrgdara can be subjected and vata kaphahara and raktapittahara treatment can be adopted here. Hence triphala guggulu mentioned in vidradhi rogadhikara which is tridoshahara, lekhana, medhohara and satavari gokshura ksheerapaka mentioned in raktapitta rogadhikara which is raktapittahara, asrajit is being used in this study. Females in the age group 25 - 45 years having sonologically diagnosed fibroids with menorrhagia and metrorrhagia will be selected from the OPD of prasutitantara and striroga, Government ayurveda college Thiruvananthapuram as per inclusion and exclusion criteria. Participants willbe advised to take 48ml kashaya as ksheerapaka twice daily before food for two consecutive months and 1.5g triphala guggulu tablet twice will be given for 20 days in each month excluding the days of menstruation. Patients will be advised to report on 31st and 61st day during study perod and 91st day for follow up. Outcome variable will be assessed using PBAC score. Changes in secondary objective will be assessed by VAS pain scale and USG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Day(s) 至 45.00 Day(s)(—)
- 性别
- Female
入选标准
- •Participants of age group between 25-45 years sonologically diagnosed with Uterine fibroids of size less than 8 cm and associated with Menorrhagia and Metrorrhagia.
排除标准
- •Fibroids with dysmenorrhea only Diagnosed case of malignancy Pregnancy and lactation Patients with Hb<8gm/dl Uncontrolled systemic illness Post menopausal women Known case of dyslipidemia Patients with bleeding disorders.
结局指标
主要结局
Change in bleeding due to uterine fibroid
时间窗: 0th day, 31st day ,61st day during study period and on 91st day during follow up
次要结局
- change in size of fibroid(0th day during study period & 91st day during follow up)
- Change in dysmenorrhea(0th day, 31st day & 61st day during study period & 91st day during follow up)
