Efficacy Of Krishnatiladi Kashyam Ghanvati As Artava Janan (Mensturation) In Patients Of Avrita Vata Artava Dushti WSR PCOS (Phenotype D)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Krishnatiladi kashayam ghanvati may act as emmenogogue
Study Overview
Brief Summary
Polycystic Ovarian Syndrome is a most common metabolic and endocrine disorder in women of reproductive age It affects an estimated 5 to13 percent females and up to 70 percent of women with PCOS worldwide remains undiagnosed Symptoms of PCOS include Amenorrhea or infrequent menstruation irregular bleeding and infrequent or no ovulation and multiple immature follicles. Later complication of PCOS is associated with type 2 diabetes heart disease and ovarian cyst. According to the Rotterdam consensus PCOS is determined by the presence of at least two out of three of the following features: evidence of oligomenorrhea (cycles greater than 35 days apart or less than 8 cycles per year) or anovulation or biochemical or clinical hyperandrogenism and Polycystic ovarian morphology greater than or equal to 12 follicles measuring two to nine mm in diameter and or an ovarian volume greater than10 mL in at least one ovary) . Phenotype D oligomenorrhoea / anovulation and PCOS without Clinical or biochemical hyperandrogenism. In Ayurvedic literature details as per PCOS is not described. It is a syndrome involving Pitta and Kapha and Rasa dhatu Dushti Dhatwagni mandya and Artava Dushti. It has been mentioned in Yogaratnakar Yonivyapchikitsa Adhyaya that after the use of decoction prepared from Krishna Tila (Sesame indicum Linn) Shelu (Cordia dichotoma Forst) and Karvi (Nigella sativa Linn) mensuration will start in three days. Krishna tila and Karvi is having Ushna Veerya these drug may initiate mensuration. So this study may evaluate the efficacy of KrishnaTiladikashayam in dosage form of ghanvati as artavajanan (emmenagogue). It may be more feasible dosage form for artavajanan on the PCOS (Phenotype D ) patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 16.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •patients having symptoms of PCOS phenotype D (oligomenorrhoea or anovulation and PCOS without Clinical or biochemical hyperandrogenism) 2 Artava kshaya and Amenorrhea or oligomenorrhea (cycles greater than 35 days apart or less than 8 cycles per year).
- •3 Endometrial thickness is greater than 5mm in ultrasonography.
Exclusion Criteria
- •Female patients having any other disease causing oligomenorrhoea and anovulation excluding PCOD on the above criteria.
- •Known case of adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, cushing’s syndrome will be excluded.
Outcomes
Primary Outcomes
Krishnatiladi kashayam ghanvati may act as emmenogogue
Time Frame: baseline 7th day and 15th day of both menstrual cycle
Secondary Outcomes
- Improvement In Symptoms Of PCOS(Amount Of Menstrual Flow Duration of Menstrual Bleeding)
Investigators
Dr. Shalini Varshney
Ayurvedic And Unani Tibbia College And Hospital
