A Randomized open-labelled controlled clinical study to evaluate the efficacy of Vishwaeladi Churna in the management Of Asrugdara with special reference to Menorrhagia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters.
研究概览
简要总结
• Menorrhagia is defined as cyclic bleeding at normal intervals; the bleeding is either excessive in amount (>80ml) or duration (>7days) or both .
• It is largely responsible for iron deficiency anaemia which has negative effects on women health. It is considered to be one of the most significant causes of ill health in women.
• Menorrhagia has significant effects on personal, social, family and work life of women thereby reducing their quality of life. It significantly lowers the quality of life for women by having an impact on their personal, social, family, and work lives.
• The condition depends largely on hormonal therapy, prostaglandin inhibitors and anti-fibrinolytic drugs which causes adverse affects like nausea, vomitting, GI disturbances, liver diseases etc. They provide only symptomatic relief without providing any definite efficacy in long term.
• Vishwaeladi Churna is explained in Sahasrayoga, Churna Prakarana.
• “Vishwaelakanamusali Gokshuravamshisita Arajastadvat
RaktasravaprashamakamPaanarthambhishajaermatam.â€
(Sahasrayoga,ChurnaPrakarana)
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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
- •Subjects with the age group of 18-45 years
- •Subjects irrespective of their marital status, religion and socio-economic status.
- •Subjects with cardinal symptoms of Asrugdara- a) Excessive blood loss during menstruation and/or b)Prolonged blood loss during menstruation.
- •Subjects with Menorrhagia- Cyclical Bleeding at normal intervals which is excessive in amount or duration.
- •Subjects willing to do self-assessment/Pictorial Blood Assessment Chart.
- •Subjects after 3 months of removal of Intra uterine contraceptive device.
- •Subjects willing to sign the consent form.
排除标准
- •Subjects between the age group of 18-45 years. Subjects irrespective of their marital status, religion and socio-economic status. Subjects with cardinal symptoms of Asrugdara.
- •a) Excessive blood loss during menstruation and/or b) Prolonged blood loss during menstruation. Subjects with Menorrhagia- Cyclical Bleeding at normal intervals which is excess in amount or duration. Subjects willing to do self assessment / Pictorial Blood Assessment Chart. Subjects willing to sign the consent form.
结局指标
主要结局
1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters.
时间窗: 1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters. | 2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia. | Study Duration: | Treatment Period -2 consecutive cycles | Duration of Study Period- 3 consecutive cycles
2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia.
时间窗: 1.Significant decrease in excessive blood loss and prolonged blood loss during menstruation, associated with pain and body ache assessed based on PBAC Scoring System , subjective and objective parameters. | 2.The efficacy of Vishwaeladi Churna will be established in the treatment of Asrugdara w.s.r to Menorrhagia. | Study Duration: | Treatment Period -2 consecutive cycles | Duration of Study Period- 3 consecutive cycles
次要结局
- 1.Generation of in - depth analysed data on the different aspect of the disease.(2.Generation of data on possible unexpected drug reaction.)
研究者
Dr Anusha Purohit
Sri Sri College of Ayurvedic Science and Research Hospital