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
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 2)Duration of menstrual cycle
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 21.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •Pregnant women.
- •Lactating women.
- •Haemoglobin less than 8 gm%.
- •Subjects with other systemic illness.
- •Subjects with any ano-rectal complaints.
Outcomes
Primary Outcomes
2)Duration of menstrual cycle
Time Frame: 31st day adn 60th day of study period
1)Number of pads used per day
Time Frame: 31st day adn 60th day of study period
Grading
Time Frame: 31st day adn 60th day of study period
Duration of menstrual cycle
Time Frame: 31st day adn 60th day of study period
Grade 0 4-7 days
Time Frame: 31st day adn 60th day of study period
Grade 1 3-4 days
Time Frame: 31st day adn 60th day of study period
Grade 2 2-3 days
Time Frame: 31st day adn 60th day of study period
Grade 3 1-2 days
Time Frame: 31st day adn 60th day of study period
Number of pads used per day
Time Frame: 31st day adn 60th day of study period
Grade 0 - 3-4 pads/day
Time Frame: 31st day adn 60th day of study period
Grade 1 - 2-3 pads/day
Time Frame: 31st day adn 60th day of study period
Grade 2 - 1-2 pads/day
Time Frame: 31st day adn 60th day of study period
Grade 3 - Spotting
Time Frame: 31st day adn 60th day of study period
Secondary Outcomes
- 1) Interval between two cycles(Grade 0 - 28-32 days)
