Effect of NAE on Polycystic Ovarian Syndrome (PCOS)

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.

Eligibility

Inclusion Criteria:

* Female subjects of reproductive age (18-40 years).
* Subjects with a diagnosis of polycystic ovary syndrome (PCOS) confirmed by clinician diagnostic criteria (Rotterdam criteria).
* Subjects with insulin resistance defined as HOMA-IR \> 2.00.

Exclusion Criteria:

* Pregnant or lactating women.
* Subjects with known Cushing's syndrome.
* Subjects with late-onset congenital adrenal hyperplasia.
* Subjects with androgen-secreting tumors.
* Subjects with uncontrolled thyroid disease.
* Subjects with hyperprolactinemia.
* Subjects with diabetes mellitus.
* Subjects with uncontrolled hypertension.
* Subjects with other cardiovascular diseases.
* Subjects with acute or chronic infections.
* Subjects with any known malignancy.
* Subjects with impaired renal function (serum creatinine \> 1.5 × ULN).
* Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN).

Conditions4

Interventions3

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• Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome — Jinnah Postgraduate Medical Centre
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