AzTrials
AzTrials

Polycystic Ovarian Syndrome (PCOS)Phase 1PCOSNCT07399535

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

A Phase 1 study testing Herbal Formulation, Metformin XR and Metformin 750 mg and herbal formulation 500 mg in people with Polycystic Ovarian Syndrome (PCOS) and Herbal Medicine, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Herbal Formulation, Metformin XR and Metformin 750 mg and herbal formulation 500 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 sitePakistan
Study dates
22 Feb 2025to 1 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Jinnah Postgraduate Medical Centre

    Karachi, Sindh

Other trials in Pakistan

About this study

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.

Read the detailed description

Polycystic Ovarian Syndrome is a point of concern these days in female population around the world.The patients feel psychological and mentally unhealthy. PCO effects around 6- 14% of women worldwide. PCOS is characterized by hormonal dis-regulation and hyperinsulinemia. Improvements in sex hormones and insulin sensitivity in PCOS women, either through lifestyle changes or through pharmaceutical intervention, have consistently resulted in a marked improvement in the reproductive and metabolic abnormalities in PCOS Commonly prescribed treatment for PCOS include oral contraceptives (OCPs), metformin, pioglitazone, estrogen, GnRH agonist, myo-inositol, letrozole and clomiphene citrate. Despite their effectiveness in symptom relief and ovulation induction, these treatments are associated with adverse effects including weight gain, cardiac issues, lactic acidosis, dysmenorrhea, and abdominal discomfort (Hussain et al., 2022). Given the limitations of conventional drugs, Herbal therapies are gaining attention for their multi-targeted ability to restore natural hormonal balance, improve ovulation and offer symptom relief with minimal side effects (Hussain et al., 2022). In this context, the present study is designed to explore the therapeutic benefits of a novel polyherbal formulation that includes Momordica charantia L., Linum usitatissimum, Symplocos racemose bark, Allium cepa L., Tribulus terrestris, and eggshell. These ingredients were selected based on their various pharmacological properties that are relevant to the pathophysiology of PCOS. This study will evaluate the safety and effectiveness of Melats P in achieving a successful menstruation regulation in PCOS women.We will recruit 3 groups , First group with conventional treatment (Metformin ) , Second with Alternative medicine having a herbal Formulation ( Melats P) and Third group patients will receive both Conventional (Metformin) and Herbal Formulationn (Melats P).

Being tested
Herbal Formulation, Metformin XR, Metformin 750 mg and herbal formulation 500 mg
Keywords
polycystic ovarian syndrome, herbal formulation, infertility
Medical subject headings
Polycystic Ovary Syndrome, Infertility, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Herbal FormulationDrug

    Also called Melats P

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

  • Metformin XRDrug

    Also called Glucophage

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

  • Metformin 750 mg and herbal formulation 500 mgDrug

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

Study groups in NCT07399535
Study groupRoleWhat they receive
Herbal formulation treated groupExperimentalHerbal formulation 500 mg twice daily for 4 months in PCOS patients
Receives: Drug: Herbal Formulation
Metformin XR treated groupActive comparatorMetformin XR 750 mg twice daily for 4 months in PCOS patients
Receives: Drug: Metformin XR
Adjunct GroupExperimentalHerbal formulation 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patient
Receives: Drug: Metformin 750 mg and herbal formulation 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 4 months

Secondary outcomes (7)

  1. Serum Follicle-Stimulating Hormone (FSH) Levels

    Change in serum follicle-stimulating hormone (FSH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 3.5 - 12.5 , Women (Ovulation Phase): 4.7 - 21.5, Women (Luteal Phase): 1.7 - 7.7

    Measured: Baseline and after 4 months

  2. Serum Luteinizing Hormone (LH) Levels

    Change in serum luteinizing hormone (LH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 1.9 - 9.2, Women (Ovulation Phase): 6.1 - 49.1, Women (Luteal Phase): 1.3 - 10.8

    Measured: Baseline and after 4 months

  3. Serum Testosterone Levels

    Change in serum testosterone levels measured using standard laboratory assays. Unit of Measure: ng/mL, Normal Range: 18-49 years: 0.084-0.481

    Measured: Baseline and after 4 months

  4. Glycated Hemoglobin (HbA1c) Level

    Change in glycated hemoglobin (HbA1c) percentage measured using standardized laboratory methods. Unit of Measure: %, Normal Range: Normal <5.6%, Prediabetes: 5.7% - 6.4%, Diabetes: 6.5% or higher

    Measured: Baseline and after 4 months

  5. Fasting Serum Insulin Concentration

    Change in fasting serum insulin concentration measured using standard laboratory assays. Unit of Measure: µIU/mL, Normal Range: 2 to 25

    Measured: Baseline and after 4 months

  6. HOMA-IR

    HOMA-IR will be calculated before and immediately after 90-day treatment. HOMA-IR is calculated using the following equation: HOMA-IR = fasting plasma glucose in mmol/L×fasting insulin in μU/ml/22.5.

    Measured: Before and after 4 months

  7. Body Weight

    Change in body weight measured using a calibrated weighing scale. Unit of Measure:

    kg

    Measured: Baseline and after 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start22 Feb 2025
  3. Primary completion22 Feb 2026
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07399535
Sponsor's protocol ID
NO.F.2-81/2024-GENL/101/JPMC
Other IDs
NO.F.2-81/2024-GENL/101/JPMC
Acronym
PCOS
Status last verified
Feb 2026
First submitted
4 Dec 2025
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36835989

  • 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.

    PubMed 33627974

  • 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.

    PubMed 30052961

  • 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.

    PubMed 31741280

  • 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.

    PubMed 36523331

  • 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.

    PubMed 27976369

  • 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.

    PubMed 30463276

  • 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.

    PubMed 35488014

  • 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.

    PubMed 26150870

  • 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.

    PubMed 14747184

  • 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.

    PubMed 23932062

  • 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.

    PubMed 32446954

  • 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.

    PubMed 17720020

  • 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.

    PubMed 29410349

  • 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.

    PubMed 19920068

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Herbal Formulation, Metformin XR and Metformin 750 mg and herbal formulation 500 mg in people with Polycystic Ovarian Syndrome (PCOS) and Herbal Medicine, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regulation of Menstrual Cycle (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07399535, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in