NCT07603505CompletedPhase 1
Effect of NAE on Polycystic Ovarian Syndrome (PCOS)
Effect of Nepeta Adenophyta Hedge Extract and Its Fractions on Polycystic Ovarian Syndrome (PCOS)
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 116 (actual)
- First submitted
- 18 May 2026
- Start date
- 10 Apr 2025
- Primary completion date
- 30 May 2026
- Lead sponsor
- Jinnah Sindh Medical University
- NCT number
- NCT07603505
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 116
- From 10 Apr 2025 to the primary completion date, 30 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with known Cushing's syndrome.
- Subjects with uncontrolled thyroid disease.
- Subjects with diabetes mellitus.
- Subjects with uncontrolled hypertension.
- Subjects with other cardiovascular diseases.
- Subjects with acute or chronic infections.
- Subjects with any known malignancy.
Lab values
- Subjects with impaired renal function (serum creatinine \> 1.5 × ULN).
- Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN).
Other
- Pregnant or lactating women.
- Subjects with late-onset congenital adrenal hyperplasia.
- Subjects with androgen-secreting tumors.
- Subjects with hyperprolactinemia.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jinnah Postgraduate Medical Centre Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.