Comparative clinical Trial to determine the effect of Shunthi-Lodhra Churna and Lajjalu Churna in management of Raktapradara w.s.r. to menorrhagia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
Title- Comparative clinical trial to determine the effect of Shunthi-Lodhra Churna and Lajjalu Churna in management of Raktapradar(Menorrhagia).
Introduction- Raktapradar means excessive menstrual bleeding in Ayurveda. Correlated with Menorrhagia (bleeding more than 80 ml or less than 7 days). Caused due to Vata-Pitta dosha vitiation. Raktapradar have Symptoms like excessive bleeding, weakness, pain, burning sensation. Menorrhagia prevalence in India is15.9 percentage. Modern treatment (hormonal therapy, antifibrinolytics) have side effects like nausea, vomiting, weight gain. Surgical options (D&C, hysterectomy) is not suitable for young women. Ayurvedic drugs are safe, economical, and effective.
Hypothesis- Null hypothesis (H0): No significant difference between both drugs.
Alternative hypothesis (H1): Significant difference exists.
Primary objective- Compare effectiveness of both drugs in reducing menstrual bleeding quantity and duration.
Secondary objectives- Assess improvement in:Pain,Weakness,Irritability.
Study design- Type of study is Open label comparative clinical study. Study duration is18 months.Treatment duration is12 weeks.
Sample size-Total sample size for study will be 80 participants divided equally between two groups.
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 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Patients who will give informed written consent for study. 2 Patients of age group 18 to 49 years (reproductive age group). 3 The patients having clinical signs and symptoms of Raktapradara.
- •Raja Ati Pravrutti (Excessive menstrual bleeding), Dirgha Kala Artava Pravrutti (Prolong menstrual bleeding more than 7 days), Vedana in Shroni Prushtha and Kukshi (Pain in the pelvic region), Yonigat Daha (Burning sensation in external genitalia), Daurbalya (Generalized Weakness), Angmard (Bodyache). 4 Hemoglobin percentage above 7 g/dl.
排除标准
- •1 K/C/O pelvic and uterine pathology like Uterine fibroid, Polyp, Pelvic inflammatory disease, Adenomyosis, Post-menopausal bleeding,malignant and non- malignant tumors.
- •2 K/C/O Any significant chronic illness.
- •3 K/C/O ectopic pregnancy, recent abortion, DUB.
- •4 K/C/O any external injury to reproductive track.
- •Patients with IUCD and OCP pills.
- •• Patients taking Anti-coagulation therapy and having any coagulant defects like Thrombocytopenic Purpura.
研究者
Dr Snehal Namdev Kakade
SST Ayurved mahavidyalay, Sangamner