Clinical Research Directory

Effect of NAE on Polycystic Ovarian Syndrome (PCOS)

Sponsor: Jinnah Sindh Medical University

Summary

Polycystic Ovarian Syndrome (PCOS) is a multifaceted endocrine metabolic condition impacting about 5-10% of women throughout their reproductive lifespan. It is influenced by neuroendocrine dysfunction, insulin resistance, chronic low-grade inflammation, and ovarian oxidative stress. Existing medications, including metformin, clomiphene citrate, and anti-androgens, provide only limited advantages and are frequently restricted by side effects such as gastrointestinal intolerance, teratogenic risks, and weight gain. NAE (family Lamiaceae) is a fragrant perennial herb indigenous to the Himalayan and sub-Himalayan areas of Pakistan and Afghanistan. Phytochemical profiling of this plant has revealed high concentrations of flavonoids (luteolin, apigenin, quercetin), phenolic acids (rosmarinic and caffeic acid), terpenoids (nepetalactones), and glycosides. In a preclinical study lasting 30 days that involved Letrozole induced PCOS in Albino Wistar rats, the oral delivery of crude extract (350 and 500 mg/kg) and its methanol/butanol fractions (64 mg/kg; 12.5mg/kg) significantly restored estrous cyclicity, decreased serum LH and testosterone levels, normalized the LH/FSH ratio, enhanced insulin sensitivity (reduced HOMA IR), corrected dyslipidaemia, and reversed ovarian histopathological alterations. Molecular analysis by qRT PCR showed upregulation of IL 4 and downregulation of AR, CYP-17, TLR4, TNF α, and NF κB. Based on this multi targeted preclinical efficacy and a favourable safety profile, this clinical trial will assess the safety and effectiveness of a standardised NAE in women with PCOS, compared to metformin and combination therapy over 4 months.

Official title: Effect of Nepeta Adenophyta Hedge Extract and Its Fractions on Polycystic Ovarian Syndrome (PCOS)

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