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Clinical Trials/CTRI/2020/04/024953
CTRI/2020/04/024953Not yet recruitingPhase 3

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 site in 1 country30 target enrollmentStarted: January 5, 2020Last updated:
Conditions

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)

Investigators

Sponsor
Dr Pavitra B
Sponsor Class
Other [self]

Study Sites (1)

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