An open labelled randomised controlled clinical study to evaluate the efficacy of Shoolaprashamana Mahakashaya phanta versus Mefenamic acid in Kashtartava Dysmenorrhea
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in scoring of VAS and MRS grading 80% reduction
研究概览
简要总结
Topic An Open Labelled Randomised Controlled Clinical Study To Evaluate The Efficacy of Shoolaprashamana Mahakashaya Phanta Versus Drotaverine In Kashtartava Dysmenorrhea
Introduction Dysmenorrhea characterized by painful menstruation, is a common gynecological issue affecting a significant portion of women worldwide. Shoolaprashamana Mahakashaya phanta an Ayurvedic formulation is proposed as an alternative treatment to conventional medication like Drotaverine . This study aims to compare the efficacy of these two treatments in managing dysmenorrhea.
Materials and Methods An open-label, randomized controlled clinical study will be conducted at Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh. Sixty patients diagnosed with dysmenorrhea will be divided into two groups with one receiving Shoolaprashamana Mahakashaya phanta (48ml BD) and the other receiving Drotaverine(40mg TDS). Pain intensity will be assessed using Medical Research Council (MRC) grading and Visual Analog Scale (VAS). Associated symptoms will also be evaluated. Statistical analysis will be performed using SPSS version 20.
Expected Outcomes The study aims to evaluate efficacy of Shoolaprashamana Mahakashaya phanta in reduction in pain scores of VAS and MRS grading and associated symptoms from baseline to the third menstrual cycle as compared to Drotaverine.
Discussion Shoolaprashamana Mahakashaya phanta may be a promising alternative to conventional medication for managing dysmenorrhea. Its efficacy in reducing pain and associated symptoms warrants further investigation in larger, long-term studies.
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
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •H/O Painful menstruation and pain few days prior to menstruation for atleast three consecutive cycle.
- •Age group of 15-49 year Patients having moderate to severe pain acc to MRC grading recommended by WHO Patient suffering from any type of menstrual pain premenstrual pain and average bleeding during periods that persisted for 3 months prior to the study will be included Patients with fibroids less than 3cm who had secondary dysmenorrhoea without menorrhagia Endometriosis Adenomyosis with regular periods and average bleeding during periods that persisted for 3 months prior to the study will be included.
排除标准
- •Carcinoma Tuberculosis Congenital anomalies Patient on hormonal therapy Patient who had pain caused by inflammatory or malignant diseases Patients were taking oral contraceptive pill IUCD suffered from chronic general illness lactating women Uterine fibroids of size greater than 3cm with menorrhagia Patient having irregular periods Abnormal Uterine Bleeding Menstrual Pain associated with Menorrhagia and Metrorrhagia Ovarian Cyst greater than 6cm.
结局指标
主要结局
Reduction in scoring of VAS and MRS grading 80% reduction
时间窗: Baseline 1st 2nd and 3rd Menstrual Cycle
次要结局
- Reduction in associated systemic symptoms Nausea Vomiting Headache Fatigue Diarrhoea(Baseline & 3rd Menstrual Cycle)
研究者
Neetika
Shri Dhanwantry Ayurvedic College and Hospital