A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRIPHLADI TAILAM MATRA BASTI AND KUBERAKSH VATI IN THE MANAGEMENT OF POLYCYSTIC OVARIAN SYNDROME (PCOS)
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Dr Pooja
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To reduce or resolve the number and size of cyst
Overview
Brief Summary
Polycystic ovarian syndrome (PCOS) is a endocrinopathy typified by oligoovulation or anovluation , signs of androgen excess and multiple small ovarian cysts.1 These signs and symptoms may very widely between women as well as within individuals over time. Risk factors that predispose females to Polycystic ovarian syndrome ( PCOS ) are lifestyle or diet, environmental pollutants, genetics , gut dysbiois neuroendorcine alternations and obesity. Obesity is a commom finding in women with Polycystic ovarian syndrome( PCOS) and between 40-80% of women with this condition are reported to be overweight or obese.2 Polycystic ovarian syndrome (PCOS) appears to equally affect all races and nationalities. The Rotterdam criteria constitute a broader spectrum that put forward by NIH (National Institutes of Health) [ESHRE/ASRM (Rotterdam) 2003]3 - It includes two out of three of the following 1 Oligo or annovulation. 2 Clinical and or biochemical signs of Hyperandrogenism . 3 Polycystic Ovaries (with exclusion of related disorders). As there is no direct mentioning of a diseases in Ayurveda which is having direct correlation with any modern diseases but all the modern diseases can be included under the broad umbrella of Ayurvedic technologies. Polycystic ovarian syndrome (PCOS) is a problem including 2 unevenness of vata and kapha mainly.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 16.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1 Patient willing to give voluntary informed consent 2 Female patient of age group between 16-40 years (both married and unmarried) ASRM / ESHRM (Rotterdam) criteria- Affected patient must follow two out of three criteria (1) Oligo and/or anovulation (2) Hyperandrogenism (clinical / biochemical) (3) Polycystic ovaries (confirmed or USG) 3 BMI more than 24.9.
Exclusion Criteria
- •1 Patient who is not willing to give voluntary informed consent 2 Women of age from 16years to 40 years 3 BMI less than 24.9 4 Patient with chronic systemic illness (cardiac failure cirrhosis of liver hypertension diabetes mellitus tuberculosis chronic renal disease) 5 Patient with reproductive system abnormalities (excluded clinically and radiologically hydrosalpinx endometrosis adenomyosis carcinoma of reproductive organ) 6 Long term medication 7 Any type of malignancy 8 Patient with positive STDs HIV Hepatitis B antigen (HBsAg) 9 Patient suffering from adrenal hyperplasia severe insulin resistant androgen secreting neoplasm thyroid abnormalities cushing syndrome.
Outcomes
Primary Outcomes
To reduce or resolve the number and size of cyst
Time Frame: FOLLOW UP FOR SUBJECTIVE SYMPTOMS AFTER EVERY 1 MONTH AND FOR OBJECTIVE SYMPTOMS AFTER 3 MONTHS
Secondary Outcomes
- Changes in other associated clinical feature related to Polycystic ovarian syndrome (PCOS)(FOLLOW UP FOR SUBJECTIVE SYMPTOMS AFTER EVERY 1 MONTH AND FOR OBJECTIVE SYMPTOMS AFTER 3 MONTHS)
Investigators
Dr Pooja
Institute for Ayurved Studies and Research Umri Road sector 08