Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome

NCT07399535 | Recruiting Phase 1 DMC

• 1 other identifier: NO.F.2-81/2024-GENL/101/JPMC
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Polycystic Ovarian Syndrome (PCO) is a metabolic disorder that afflicts the women of childbearing age. An approximate of 5-10% women are the victim of this disorder. PCOS is a leading cause of infertility in females these days and is characterized by Hyperandrogenism, Chronic Anovulation, Impaired fertility, obesity, Hirsutism, Acne, Obesity, Metabolic disturbances (dyslipidemias, Hyperinsulinemia, insulin resistance, and type- 2 diabetes), and Endometrial Hyperplasia. This study will test a combination of herbal medications (Melats P) in women with PCOS to determine which works best to overcome infertility.

Conditions

Polycystic Ovarian Syndrome (PCOS); Herbal Medicine; Infertility; Metabolic Disorder

Keywords

polycystic ovarian syndrome; herbal formulation; infertility

Outcome Measures

Primary Outcomes (1)

• Regulation of Menstrual Cycle

  Improvement and restoration of regular ovulatory menstrual cycles ( cycle length 21-35 days) after 4 months of treatment, assessed through menstrual history and ultrasonographic confirmation of ovulation. Ovulation confirmed by transvaginal ultrasonography, defined by the presence of a dominant follicle followed by follicular rupture during the treatment period.

  Baseline to 4 months

Secondary Outcomes (7)

• Serum Follicle-Stimulating Hormone (FSH) Levels

  Baseline and after 4 months

• Serum Luteinizing Hormone (LH) Levels

  Baseline and after 4 months

• Serum Testosterone Levels

  Baseline and after 4 months

• Glycated Hemoglobin (HbA1c) Level

  Baseline and after 4 months

• Fasting Serum Insulin Concentration

  Baseline and after 4 months

Other Outcomes (1)

• Assessment of quality of life via Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL)

  Before and after 4 months

Study Arms (3)

Herbal formulation treated group

EXPERIMENTAL

Herbal formulation 500 mg twice daily for 4 months in PCOS patients

Drug: Herbal Formulation

Metformin XR treated group

ACTIVE COMPARATOR

Metformin XR 750 mg twice daily for 4 months in PCOS patients

Drug: Metformin XR

Adjunct Group

EXPERIMENTAL

Herbal formulation 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patient

Drug: Metformin 750 mg and herbal formulation 500 mg

Interventions

Herbal Formulation DRUG

Herbal Formulation 500mg twice daily for 4 months in PCOS patients

Also known as: Melats P

Herbal formulation treated group

Metformin XR DRUG

Metformin XR 750mg twice daily for 4 months in PCOS patients

Also known as: Glucophage

Metformin XR treated group

Metformin 750 mg and herbal formulation 500 mg DRUG

Herbal formulation and Metformin twice daily for 4 months in PCOS patients

Adjunct Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female subjects in reproductive age (i.e. 18-40 years)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (18)

• Singh S, Pal N, Shubham S, Sarma DK, Verma V, Marotta F, Kumar M. Polycystic Ovary Syndrome: Etiology, Current Management, and Future Therapeutics. J Clin Med. 2023 Feb 11;12(4):1454. doi: 10.3390/jcm12041454.

  PMID: 36835989 BACKGROUND

• Deswal R, Narwal V, Dang A, Pundir CS. The Prevalence of Polycystic Ovary Syndrome: A Brief Systematic Review. J Hum Reprod Sci. 2020 Oct-Dec;13(4):261-271. doi: 10.4103/jhrs.JHRS_95_18. Epub 2020 Dec 28.

  PMID: 33627974 BACKGROUND

• Teede HJ, Misso ML, Costello MF, Dokras A, Laven J, Moran L, Piltonen T, Norman RJ; International PCOS Network. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Hum Reprod. 2018 Sep 1;33(9):1602-1618. doi: 10.1093/humrep/dey256.

  PMID: 30052961 BACKGROUND

• Moini Jazani A, Nasimi Doost Azgomi H, Nasimi Doost Azgomi A, Nasimi Doost Azgomi R. A comprehensive review of clinical studies with herbal medicine on polycystic ovary syndrome (PCOS). Daru. 2019 Dec;27(2):863-877. doi: 10.1007/s40199-019-00312-0. Epub 2019 Nov 18.

  PMID: 31741280 BACKGROUND

• Dastgheib M, Barati-Boldaji R, Bahrampour N, Taheri R, Borghei M, Amooee S, Mohammadi-Sartang M, Wong A, Babajafari S, Mazloomi SM. A comparison of the effects of cinnamon, ginger, and metformin consumption on metabolic health, anthropometric indices, and sexual hormone levels in women with poly cystic ovary syndrome: A randomized double-blinded placebo-controlled clinical trial. Front Nutr. 2022 Nov 29;9:1071515. doi: 10.3389/fnut.2022.1071515. eCollection 2022.

  PMID: 36523331 BACKGROUND

• Brown J, Farquhar C. Clomiphene and other antioestrogens for ovulation induction in polycystic ovarian syndrome. Cochrane Database Syst Rev. 2016 Dec 15;12(12):CD002249. doi: 10.1002/14651858.CD002249.pub5.

  PMID: 27976369 BACKGROUND

• Wolf WM, Wattick RA, Kinkade ON, Olfert MD. Geographical Prevalence of Polycystic Ovary Syndrome as Determined by Region and Race/Ethnicity. Int J Environ Res Public Health. 2018 Nov 20;15(11):2589. doi: 10.3390/ijerph15112589.

  PMID: 30463276 BACKGROUND

• Motlagh Asghari K, Nejadghaderi SA, Alizadeh M, Sanaie S, Sullman MJM, Kolahi AA, Avery J, Safiri S. Burden of polycystic ovary syndrome in the Middle East and North Africa region, 1990-2019. Sci Rep. 2022 Apr 29;12(1):7039. doi: 10.1038/s41598-022-11006-0.

  PMID: 35488014 BACKGROUND

• Arain F, Arif N, Halepota H. Frequency and outcome of treatment in polycystic ovaries related infertility. Pak J Med Sci. 2015;31(3):694-9. doi: 10.12669/pjms.313.8003.

  PMID: 26150870 BACKGROUND

• Jones GL, Benes K, Clark TL, Denham R, Holder MG, Haynes TJ, Mulgrew NC, Shepherd KE, Wilkinson VH, Singh M, Balen A, Lashen H, Ledger WL. The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ): a validation. Hum Reprod. 2004 Feb;19(2):371-7. doi: 10.1093/humrep/deh048.

  PMID: 14747184 BACKGROUND

• Zegers-Hochschild F, Dickens BM, Dughman-Manzur S. Human rights to in vitro fertilization. Int J Gynaecol Obstet. 2013 Oct;123(1):86-9. doi: 10.1016/j.ijgo.2013.07.001. Epub 2013 Aug 6.

  PMID: 23932062 BACKGROUND

• Wasilewski T, Lukaszewicz-Zajac M, Wasilewska J, Mroczko B. Biochemistry of infertility. Clin Chim Acta. 2020 Sep;508:185-190. doi: 10.1016/j.cca.2020.05.039. Epub 2020 May 21.

  PMID: 32446954 BACKGROUND

• Norman RJ, Dewailly D, Legro RS, Hickey TE. Polycystic ovary syndrome. Lancet. 2007 Aug 25;370(9588):685-97. doi: 10.1016/S0140-6736(07)61345-2.

  PMID: 17720020 BACKGROUND

• Murri M, Insenser M, Fernandez-Duran E, San-Millan JL, Luque-Ramirez M, Escobar-Morreale HF. Non-targeted profiling of circulating microRNAs in women with polycystic ovary syndrome (PCOS): effects of obesity and sex hormones. Metabolism. 2018 Sep;86:49-60. doi: 10.1016/j.metabol.2018.01.011. Epub 2018 Feb 2.

  PMID: 29410349 BACKGROUND

• Dickerson EH, Cho LW, Maguiness SD, Killick SL, Robinson J, Atkin SL. Insulin resistance and free androgen index correlate with the outcome of controlled ovarian hyperstimulation in non-PCOS women undergoing IVF. Hum Reprod. 2010 Feb;25(2):504-9. doi: 10.1093/humrep/dep393. Epub 2009 Nov 17.

  PMID: 19920068 BACKGROUND

• Azziz R, Woods KS, Reyna R, Key TJ, Knochenhauer ES, Yildiz BO. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004 Jun;89(6):2745-9. doi: 10.1210/jc.2003-032046.

  PMID: 15181052 BACKGROUND

• Sidra S, Tariq MH, Farrukh MJ, Mohsin M. Evaluation of clinical manifestations, health risks, and quality of life among women with polycystic ovary syndrome. PLoS One. 2019 Oct 11;14(10):e0223329. doi: 10.1371/journal.pone.0223329. eCollection 2019.

  PMID: 31603907 BACKGROUND

• Shakil M, Ashraf F, Wajid A. Sexual functioning as predictor of depressive symptoms and life satisfaction in females with Polycystic Ovary Syndrome (PCOS). Pak J Med Sci. 2020 Nov-Dec;36(7):1500-1504. doi: 10.12669/pjms.36.7.2562.

  PMID: 33235564 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility; Metabolic Diseases

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Saba Zubair, PhD scholar

  University of Sindh Jamshoro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saba Zubair, PhD Scholar

CONTACT

+923313613089; saba.zubair1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: February 10, 2026
• Study Start: February 22, 2025
• Primary Completion: February 22, 2026
• Study Completion: March 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)