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Clinical Trials/CTRI/2018/05/013951
CTRI/2018/05/013951RecruitingNot Applicable

an open label single arm clinical study to evaluate the combined effect of mrdu vamana and palasa twak kashaya in artavakshaya in diagnosed case of polycystic ovarian disease.

AKHILA AK1 site in 1 country20 target enrollmentStarted: July 12, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Change in

Study Overview

Brief Summary

This study is to assess the combined effect of mrdu vamana  and palasa twak kashaya  in artavakshaya in diagnosed case of polycystic ovarian disease. Ashta Choornam 12 gm for 2 days before food, then sukumara ghrtam 25 gm bd with rice gruel prepared with milk and salt for 3 days. SABS for 1 day with dhanwantara thailam and kapha vridhikara diet followed by mrdu vamana with yastimadhu phanta, ksheera and samsarjana krama based on suddhi.  Thereafter palasa twak kashaya (1 pala i.e. 48 grm kashaya choornam in 16 pala i.e. 768 ml water reduced to 1/8 i.e. 2 pala i.e. 96 ml daily) is given till the onset of second menstrual cycle. The mrdu vamana karma will be done for the 1st cycle only.  The study will be done  for two consecutive cycle and assessed for the parameters of mentrual bleeding and interval before treatment and after treatment using menstrual chart and PBAC chart The data collected will be formulated and analysed according to appropriate statistical method

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 35.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Age group 18 to 35 Both married and unmarried Patients with polycystic ovary in USG.
  • •Either flow duration ≤ 2 days or PBAC score ≤ 15.

Exclusion Criteria

  • •Menstrual cycle < 21 days or > 64 days Known case of TFT disturbance Lactating mother Patient taking OCP/IUCD Under anti-psychotic, anti-epileptic drugs Known case of tumors of adrenal or pituitary gland Patient having systemic pathology like TB, DM, HTN etc.

Outcomes

Primary Outcomes

Change in

Time Frame: 7th day of 2nd menstrual cycle

1)Duration of menstrual phase

Time Frame: 7th day of 2nd menstrual cycle

2)Interval between 2 cycles

Time Frame: 7th day of 2nd menstrual cycle

3)Amount of bleeding

Time Frame: 7th day of 2nd menstrual cycle

Secondary Outcomes

  • Understanding of artavakshaya in modern terms(18 months)

Investigators

Sponsor
AKHILA AK
Sponsor Class
Other [self]

Study Sites (1)

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