Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Metabolic Disorders | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herbal Formulation | Drug | — | UNRESOLVED |
| Metformin 750 mg and herbal formulation 500 mg | Drug | — | UNRESOLVED |
| Metformin XR | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NAE treated group
- description
- NAE 500 mg twice daily for 4 months in PCOS patients
- interventionNames
- Drug: Herbal Formulation
- type
- ACTIVE_COMPARATOR
- label
- Metformin XR treated group
- description
- Metformin XR 750 mg twice daily for 4 months in PCOS patients
- interventionNames
- Drug: Metformin XR
- type
- EXPERIMENTAL
- label
- Adjunct Group
- description
- NAE 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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).
References
Publications (13)
- BACKGROUNDHosseini S, Shabani F, Nayebzadeh M, Asadi F, Kabiranaraki Y, Asadpour M, Golavar Y, Asadi S, Etezadi A. Neutrophils and NETosis in polycystic ovary syndrome: unraveling the immuno-metabolic thromboinflammatory axis. Eur J Med Res. 2026 Jan 27;31(1):331. doi: 10.1186/s40001-026-03927-7. PMID 41593809
- BACKGROUNDHouston EJ, Templeman NM. Reappraising the relationship between hyperinsulinemia and insulin resistance in PCOS. J Endocrinol. 2025 Mar 12;265(2):e240269. doi: 10.1530/JOE-24-0269. Print 2025 May 1. PMID 40013621
- BACKGROUNDZeber-Lubecka N, Ciebiera M, Hennig EE. Polycystic Ovary Syndrome and Oxidative Stress-From Bench to Bedside. Int J Mol Sci. 2023 Sep 15;24(18):14126. doi: 10.3390/ijms241814126. PMID 37762427
- BACKGROUNDZhao W, Li M, Jia C, Ali I, Chen L. Anti-inflammatory effect of a pimarane diterpenoid isolated from Nepeta adenophyta Hedge based on a network analysis approach and experimental assessment. Front Pharmacol. 2025 Dec 18;16:1652902. doi: 10.3389/fphar.2025.1652902. eCollection 2025. PMID 41487516
- BACKGROUNDDashti S, Ashouri A, Bahri N. Herbal compounds in the treatment of polycystic ovary syndrome: an updated systematic review. J Ovarian Res. 2026 Feb 27;19(1):132. doi: 10.1186/s13048-026-02030-z. PMID 41761211
- BACKGROUNDLi C, Chen L, Zhao Y, Chen S, Fu L, Jiang Y, Gao S, Liu Z, Wang F, Zhu X, Rao J, Zhang J, Zhou X. Altered expression of miRNAs in the uterus from a letrozole-induced rat PCOS model. Gene. 2017 Jan 20;598:20-26. doi: 10.1016/j.gene.2016.10.033. Epub 2016 Oct 21. PMID 27777110
- BACKGROUNDSharma A, Cooper R, Bhardwaj G, Cannoo DS. The genus Nepeta: Traditional uses, phytochemicals and pharmacological properties. J Ethnopharmacol. 2021 Mar 25;268:113679. doi: 10.1016/j.jep.2020.113679. Epub 2020 Dec 8.