A Randomized open- labelled controlled clinical study to evaluate the efficacy of Jeevantyadi Yamaka Matra Basti in the management of Artava Kshaya with special reference to Oligomenorrhea
试验速览
- 阶段
- 2/3 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 symptoms of Artavakshaya with special reference to Oligomenorrhea based on assessment criteria.
研究概览
简要总结
In the current era, emphasizing the significance of women’s health is crucial. While maintaining good health should be a priority but women are entangled in demanding routines and may not allocate sufficient time to ensure their health and well-being.
Menstruation is a vital sign of a women’s reproductive and overall health, menstrual irregularities can signal underlying medical conditions.
The word Artava encompasses menstruation, menstrual blood, as well as ovum and ovarian hormones.
Artava Vyapat has become increasingly prevalent in the modern era due to unhealthy dietary patterns, sedentary lifestyles, heightened stress levels, and other contributing factors.
Oligomenorrhea is the term used to describe Menstrual bleeding occurring more than 35 days apart and which remains constant at that frequency.
Basti Karma is one of the effective treatment that can be employed in the treatment of Artava Kshaya as it helps in Shodhana of Shrotas.
Matra Basti is a type of Anuvasana Basti in which the low dose of Sneha is administered with no major contraindication.
In order to treat Rajo Dosha ,Jeevantyadi Yamaka is considered, as the drugs in the formulation have properties to enhance the Rasa Dhatu which in turn acts on its Upadhathu - Artava..
Hence Matra Basti with Jeevantyadi Yamaka is opted as the treatment of choice in Artavakshaya aiming to eradicate the disease at its core.
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
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects between the age group of 20- 40 years.
- •Subjects irrespective of marital status and parity.
- •Subjects presenting the classical symptoms of Artavakshaya.
- •Subjects with symptoms of Oligomenorrhea.
- •Subjects suffering from Artavakshaya for more than 2 cycles.
- •Subjects with spotting/bleeding less than 2 days.
- •Subjects with or without pain during menstruation.
- •Subjects after 3 months of withdrawal of oral contraceptive pills and removal of intra uterine contraceptive device.
- •Subjects willing to sign the consent form.
排除标准
- •Subjects who are pregnant and lactating mothers.
- •Subjects with hemoglobin less than 10g%.
- •Subjects with known case of hemorrhoids, fistula, fissures.
- •Subjects with known case of chronic systemic illness and malignancy.
结局指标
主要结局
1.Significant decrease in symptoms of Artavakshaya with special reference to Oligomenorrhea based on assessment criteria.
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
a.Interval between two cycles
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
b.Amount of menstrual bleeding loss.
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
c.Duration of menstrual flow
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
d.Intensity of pain during menstruation.
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
e.Assessment of pain- Grading by VMS.
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
2.The efficacy of Jeevantyadi Yamaka Matra Basti will be established in the treatment of Artavakshaya.
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
Efficacy shall be assessed based on assessment criteria mentioned above.
时间窗: Pre assessment-0th day | 1st assessment-1st cycle after treatment- 1month | Follow up-2nd cycle without treatment- 2 month
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 Aishwarya B
Sri Sri College of Ayurvedic Science and Research