CTRI/2024/07/070976尚未招募3 期
A comparative clinical study to evaluate the effect of Boladi Vati and Kanyalohadi Vati in the management of Artava Kshaya (Oligomenorrhea)
Dr Roopa Sangolli1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of trial drug on improvement in the symptoms of Artava kshaya(Oligomenorrhea)
研究概览
简要总结
- Ayurveda describes Menstrual Disorders under the heading Astha artava dushti, Asrigdara, Artava Kshaya, Nastartava, Yoni vyapad.
- Artava kshaya is one among them with involving Apana Vata and Kapha causing obstruction in the passage of Artava and it is characterized by Yathochita kalat adarshana(prolonged inter-menstrual cycle), Alpata(Reduced flow), Yoni Vedana(pain in vagina).
- This can be correlated with oligomenorrhea. It is defined as menstrual bleeding occurring more than 35 days apart and which remains constant at that frequency.
- In this study Boladi Vati is selected as trial drug for the management of Artava Kshaya (Oligomenorrhea)and its efficacy is compared with Kanyalohadi Vati.
- This is a randomized controlled clinical trial. Total 40 patient of Artava Kshaya who fulfil the inclusion criteria & diagnostic criteria based on clinical sign and symptoms of Artava Kshaya will be selected. Total Study duration will be 60 days and contain 3 visits (0th day, 5th day of first cycle and 5th day of second consecutive cycle), which includes administration of trial drug for 30 days for one cycle and post medication follow up on 5th day first and second consecutive cycle.
- After study, data will be collected from case report form (CRF) and statistically analysed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis results and conclusion will be drawn.
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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Menses at an interval longer than 35 days.
- •2.Bleeding less than 2 days 3.Both married and unmarried.
- •4.Reduced flow i.e. less than 1 pad per day.
- •5.Pain in vagina.
排除标准
- •1.Pregnant and Lactating women.
- •2.Woman on OCPs and IUCD 3.Hb% less than 8gm 4.K/C/O Pelvic Pathology or Malignancy 5.Systemic Disease which interferes with the management of Artava Kshaya.
结局指标
主要结局
Effect of trial drug on improvement in the symptoms of Artava kshaya(Oligomenorrhea)
时间窗: 5th day of Two consecutive cycles)
次要结局
- Safety of the trial drug and Adverse Drug Reaction and aggravation in the symptoms of Artava Kshaya(Oligomenorrhea)(5th day of Two consecutive cycles)
研究者
Dr Roopa Sangolli
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre
研究点 (1)
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