Health Condition 1: N915- Oligomenorrhea, unspecified
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Females with Nashtartava(PCOS) having two out of three criteria (ASRM/ESHRE Rotterdam criteria 2023) Oligo and or anovulation Hyperandrogenism clinically and or biochemically Polycystic ovaries confirmed in USG 2 Duration of flow less than previous normal physiological flow 3 Interval between two cycles exceedingly more than 35 days 4 Female patients of age group between 18to40 years (both married and unmarried)
Exclusion criteria
Exclusion criteria: 1) Other androgen excess disorders such as adrenal hyperplasia, androgen producing tumours, Cushing syndrome 2) Other uncontrolled systemic, and ovulatory disorders such as thyroid dysfunction, hyperprolactinemia etc. 3) Patient having congenital and structural abnormalities of uterus and adnexa. 4) Lactating mother, pregnant women 5) Patient using oral contraceptive pills 6) Patient taking any concomitant medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in menstrual parameter (interval, duration and amount) in females with Nashtartava(PCOS) after administration of trial drug for 3 months. Timepoint: Efficacy of trial drug in females with Nashtartava ( PCOS) after administration for 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in other associated clinical features in females with Nashtartava ( PCOS) (i.e. acne, hirsutism, obesity etc.) after administration of trial drug for3 months. Reduction in size and number of poly cystic ovaries appearance in females with Nashtartava ( PCOS) in USG after administration of trial drug for 3 months. Reduction in LH/FSH ratio levels in females with Nashtartava ( PCOS) after administration of trial drug for 3 months. Timepoint: Safety (LFT, RFT) and tolerability of trial drug in females with Nashtartava ( PCOS) after administration for 3 months | — |
Countries
India
Contacts
Nayional Institute of Ayurveda, Deemed to be University