跳至主要内容
临床试验/CTRI/2020/04/024953
CTRI/2020/04/024953尚未招募3 期

A Randomised Controlled Clinical study to evaluate the efficacy of Arkapushpa taila matra basti in the management of Artava Kshaya with special reference to Oligomenorrhea

Dr Pavitra B1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月5日最近更新:
适应症

试验速览

阶段
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
2)Duration of menstrual cycle

研究概览

简要总结

Woman’s health is the primary factor to be considered for wellbeing of family, society and culture. Any physical,physiological disorder disturbs the woman’slife. Physiological changes and development occur from birth butmarkedly during reproductive period. Stress and change in lifestyle leads tomany gynaecological problems. Among all the Gynaecological problems, the mostcommon one is menstrual irregularities i.e. in the form of ar- tava kshaya.

Artava kshaya is that condition in which menstruation fails to occur atappropriate time (delayed) with scanty flow and does not last for 3 days.

A similar entity in modern classics where menstrualbleeding occurs more than 35days apart and which remains constant at thatfrequency is called Oligomenorrhea.

About 30% women in theirreproductive life suffer from irregular periods. Among these menstrualirregularities

Oligomenorrhea accounts to 18.3%.

The treatment opted in modern system of medicine isHormonal therapy, which may have adverse effect on body like obesity, nausea,vomiting, endometrial cancer and breast cancer.

So, to prevent thesehazards and to maintain healthy life, safe ayurvedic non-hormonal therapy isrequired. In this regard, the treatment principle explained by Kashyapa for Artava kshaya is taken for study.He considers it as an Anuvasanasadhya vyadhi. Matra basti is a type of Anuvasanabasti in which the quantity of Sneha forMatra basti is 1/4th of Sneha basti.It can be given at any time without any strictrestriction on diet and activity. Arkapushpa taila is artavapravartaka,laghu in guna,has ushnavirya and *katuvipaka.*Thus, taking the treatment principle into consideration an agneya dravya i.e.Arkapushpa taila is chosen for Matra basti in Artava kshaya.

OBJECTIVES OF THE STUDY:•         To evaluate the effect of Arkapushpa taila matra basti in themanagement of Artava kshaya.

•         To evaluate the effect of Shatapushpataila matra basti in themanagement of Artava kshaya.

•         To compare the efficacy of Arkapushpataila and Shatapushpa taila matra bastiin the management of Artava kshaya.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
21.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • •Subjects age between 21 to 35 years.
  • •Subjects presenting the classical symptoms.
  • •subjects presenting with symptoms of oligomenorrhea.
  • •spotting/ bleeding less than 2 days.
  • •Both married and unmarried.
  • •subjects willing for Basti karma.

排除标准

  • •Pregnant women.
  • •Lactating women.
  • •Haemoglobin less than 8 gm%.
  • •Subjects with other systemic illness.
  • •Subjects with any ano-rectal complaints.

结局指标

主要结局

2)Duration of menstrual cycle

时间窗: 31st day adn 60th day of study period

1)Number of pads used per day

时间窗: 31st day adn 60th day of study period

Grading

时间窗: 31st day adn 60th day of study period

Duration of menstrual cycle

时间窗: 31st day adn 60th day of study period

Grade 0 4-7 days

时间窗: 31st day adn 60th day of study period

Grade 1 3-4 days

时间窗: 31st day adn 60th day of study period

Grade 2 2-3 days

时间窗: 31st day adn 60th day of study period

Grade 3 1-2 days

时间窗: 31st day adn 60th day of study period

Number of pads used per day

时间窗: 31st day adn 60th day of study period

Grade 0 - 3-4 pads/day

时间窗: 31st day adn 60th day of study period

Grade 1 - 2-3 pads/day

时间窗: 31st day adn 60th day of study period

Grade 2 - 1-2 pads/day

时间窗: 31st day adn 60th day of study period

Grade 3 - Spotting

时间窗: 31st day adn 60th day of study period

次要结局

  • 1) Interval between two cycles(Grade 0 - 28-32 days)

研究者

发起方
Dr Pavitra B
申办方类型
Other [self]

研究点 (1)

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