Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 12:48 PM
Study NCT ID:
NCT07399535
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment of quality of life via Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL)', 'timeFrame': 'Before and after 4 months', 'description': "The Polycystic Ovary Syndrome Quality of Life Scale (PCOSQOL) is a disease-specific questionnaire used to assess the impact of polycystic ovary syndrome on quality of life. It evaluates five domains: Emotions (8 items), Body Hair (5 items), Weight (5 items), Infertility Problems (4 items), and Menstrual Problems (4 items). Cronbach's alpha were above 0.7 when the PCOSQL was validated (Jones et al., 2004). It has 26 items and uses a 7-point Likert-type scale.\n\nScale Range:\n\nMinimum value: 1 Maximum value: 7\n\nLower scores indicate decreased quality of life, while higher scores indicate improved quality of life."}], 'primaryOutcomes': [{'measure': 'Regulation of Menstrual Cycle', 'timeFrame': 'Baseline to 4 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Serum Follicle-Stimulating Hormone (FSH) Levels', 'timeFrame': 'Baseline and after 4 months', 'description': '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'}, {'measure': 'Serum Luteinizing Hormone (LH) Levels', 'timeFrame': 'Baseline and after 4 months', 'description': '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'}, {'measure': 'Serum Testosterone Levels', 'timeFrame': 'Baseline and after 4 months', 'description': 'Change in serum testosterone levels measured using standard laboratory assays. Unit of Measure: ng/mL, Normal Range: 18-49 years: 0.084-0.481'}, {'measure': 'Glycated Hemoglobin (HbA1c) Level', 'timeFrame': 'Baseline and after 4 months', 'description': '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'}, {'measure': 'Fasting Serum Insulin Concentration', 'timeFrame': 'Baseline and after 4 months', 'description': 'Change in fasting serum insulin concentration measured using standard laboratory assays. Unit of Measure: µIU/mL, Normal Range: 2 to 25'}, {'measure': 'HOMA-IR', 'timeFrame': 'Before and after 4 months', 'description': '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.'}, {'measure': 'Body Weight', 'timeFrame': 'Baseline and after 4 months', 'description': 'Change in body weight measured using a calibrated weighing scale. Unit of Measure:\n\nkg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polycystic ovarian syndrome', 'herbal formulation', 'infertility'], 'conditions': ['Polycystic Ovarian Syndrome (PCOS)', 'Herbal Medicine', 'Infertility', 'Metabolic Disorder']}, 'referencesModule': {'references': [{'pmid': '36835989', 'type': 'BACKGROUND', 'citation': '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': '33627974', 'type': 'BACKGROUND', 'citation': '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': '30052961', 'type': 'BACKGROUND', 'citation': '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': '31741280', 'type': 'BACKGROUND', 'citation': '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': '36523331', 'type': 'BACKGROUND', 'citation': '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': '27976369', 'type': 'BACKGROUND', 'citation': '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': '30463276', 'type': 'BACKGROUND', 'citation': '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': '35488014', 'type': 'BACKGROUND', 'citation': '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': '26150870', 'type': 'BACKGROUND', 'citation': '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': '14747184', 'type': 'BACKGROUND', 'citation': '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': '23932062', 'type': 'BACKGROUND', 'citation': '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': '32446954', 'type': 'BACKGROUND', 'citation': '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': '17720020', 'type': 'BACKGROUND', 'citation': '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': '29410349', 'type': 'BACKGROUND', 'citation': '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': '19920068', 'type': 'BACKGROUND', 'citation': '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': '15181052', 'type': 'BACKGROUND', 'citation': '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': '31603907', 'type': 'BACKGROUND', 'citation': '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': '33235564', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female subjects in reproductive age (i.e. 18-40 years)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female subjects of reproductive age (18-40 years).\n* Subjects with a diagnosis of polycystic ovary syndrome (PCOS) confirmed by clinician diagnostic criteria.\n* Subjects with insulin resistance defined as HOMA-IR \\> 2.00.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Subjects with known Cushing's syndrome.\n* Subjects with late-onset congenital adrenal hyperplasia.\n* Subjects with androgen-secreting tumors.\n* Subjects with uncontrolled thyroid disease.\n* Subjects with hyperprolactinemia.\n* Subjects with diabetes mellitus.\n* Subjects with uncontrolled hypertension.\n* Subjects with other cardiovascular diseases.\n* Subjects with acute or chronic infections.\n* Subjects with any known malignancy.\n* Subjects with impaired renal function (serum creatinine \\> 1.5 × ULN).\n* Subjects with impaired liver function (serum ALT ≥ 2.5 × ULN)."}, 'identificationModule': {'nctId': 'NCT07399535', 'acronym': 'PCOS', 'briefTitle': 'Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jinnah Postgraduate Medical Centre'}, 'officialTitle': 'Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': 'NO.F.2-81/2024-GENL/101/JPMC'}, 'secondaryIdInfos': [{'id': 'NO.F.2-81/2024-GENL/101/JPMC', 'type': 'OTHER', 'domain': 'Jinnah Postgraduate Medical Centre Karachi'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Herbal formulation treated group', 'description': 'Herbal formulation 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': 'Herbal formulation 500 mg and Metformin XR 750 mg twice daily for 4 months in PCOS patient', 'interventionNames': ['Drug: Metformin 750 mg and herbal formulation 500 mg']}], 'interventions': [{'name': 'Herbal Formulation', 'type': 'DRUG', 'otherNames': ['Melats P'], 'description': 'Herbal Formulation 500mg twice daily for 4 months in PCOS patients', 'armGroupLabels': ['Herbal formulation treated group']}, {'name': 'Metformin XR', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Metformin XR 750mg twice daily for 4 months in PCOS patients', 'armGroupLabels': ['Metformin XR treated group']}, {'name': 'Metformin 750 mg and herbal formulation 500 mg', 'type': 'DRUG', 'description': 'Herbal formulation and Metformin twice daily for 4 months in PCOS patients', 'armGroupLabels': ['Adjunct Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'facility': 'Jinnah Postgraduate Medical Centre', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Saba Zubair, PhD Scholar', 'role': 'CONTACT', 'email': 'saba.zubair1@gmail.com', 'phone': '+923313613089'}], 'overallOfficials': [{'name': 'Saba Zubair, PhD scholar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sindh Jamshoro'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinnah Postgraduate Medical Centre', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Saba Zubair', 'investigatorAffiliation': 'Jinnah Postgraduate Medical Centre'}}}}