A Randomized Comparative Exploratory Clinical Trail to Evaluate The Efficacy of Ashoka Twak Ghana Vati and Kanchanar Twak Ghana Vati Along With Darvyadi Kwath Siddha Taila Matra Basti On Garbhshaya Arbuda W.S.R. To Uterine Fibroid.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Uterine Fibroid is the most common benign tumor of the uterus and is a major cause of menstrual disturbances, pelvic pain, infertility, and hysterectomy in women of reproductive age . From an Ayurvedic perspective ,uterine fibroid can be correlated with Garbhashaya Arbuda ,a condition predominently involving Vata-Kapha dosha with Mamsa, Meda, and Rakta dhatu vitiation.conventional management options are often invasive or hormone dependent, prompting the need for safe ,non invasive alternatives.
this randomized,comparative ,exploratory clinical trial is designed to evalute and compare the efficacy of Ashoka Twak Ghana Vati and Kanchanar Ghana Vati,each administered along with Darvyadi Kwath Siddha Taila Matra Basti, in the management of Garbhashaya Arbuda with special reference to uterine fibroid.
A total of 60 patients diagnosed with uterine fibroid less than five centimeter will be randomly allocated into two groups of 30 patients each. Group A will receive Ashoka Twak Ghana Vati (500 mg twice daily) along with Darvyadi Kwath Siddha Taila Matra Basti, while Group B will receive Kanchanar Twak Ghana Vati (500 mg twice daily) along with the same Matra Basti regimen. The duration of oral medication will be 90 days, and Matra Basti will be administered for 7 days in the follicular phase for three consecutive menstrual cycles.
The primary outcome measure will be improvement in clinical signs and symptoms of uterine fibroid, including menstrual bleeding pattern, pain, and cycle regularity. The secondary outcome measure will be reduction in the size of fibroid as assessed by ultrasonography. The study aims to generate evidence regarding the comparative effectiveness of these Ayurvedic interventions as conservative, non-surgical management options for uterine fibroid
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
- 25.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Patient who are willing for trial.
- •2.Single or multiple uterine fibroids of size up to 5 cm.
- •3.Female patient between age of 25-50 years.
- •4.The patient either asymptomatic or having clinical signs and symptoms of fibroid.
排除标准
- •Patient having bleeding due to abortion or any other pathological condition
- •Patients having coagulation disorders.
- •Pregnant women with fibroid.
- •Patient having any systemic disease like uncontrolled hypertension, diabetes mellitus.
- •Patients with active malignancies.
- •Large size uterine fibroid with pressure symptoms.
研究者
Dr Aditi Jain
Madan Mohan Malviya Govt. Ayurved College Udaipur
