Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:19 AM
Study NCT ID:
NCT06659406
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'D014451', 'term': 'Ubiquinone'}], 'ancestors': [{'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of coenzyme q10 administration on polycystic ovary syndrome', 'timeFrame': 'from enrollment to the end of treatment at 12 weeks', 'description': 'Improvement in levels of oxidative stress , inflammatory and hyperandrogenism biomarkers in women with Polycystic ovary syndrome'}, {'measure': 'The effect of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome', 'timeFrame': 'from enrollment to the end of treatment at 12 weeks', 'description': 'Oxidative stress in PCOS is leads to imbalance in antioxidant and oxidant levels in the body, along with production of reactive oxygen species. Insulin resistance has a key role in the PCOS pathogenesis by promoting oxidative stress and promoting acute and chronic Inflammation. Studies have shown that inflammatory markers are raised in PCOS along with decreased levels of anti-inflammatory biomarkers. Coenzyme Q10 is a natural vitamin, acts as an antioxidant, have shown an constructive impact on inflammatory and endothelial dysfunction biomarkers and also effects androgen levels. Effect of Coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism will be accessed by biomarkers Malondialdehyde MDA, C-reactive protein CRP and Sex hormone binding globulin SHBG. Ideally levels of MDA, CRP would decrease and SHBG levels would increase after Coenzyme Q10 supplementation. This study would measure these three biomarkers before and after the intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS'], 'conditions': ['Polycystic Ovarian Syndrome (PCOS)']}, 'referencesModule': {'references': [{'pmid': '38025704', 'type': 'BACKGROUND', 'citation': 'Hu X, Wang W, Su X, Peng H, Tan Z, Li Y, Huang Y. Comparison of nutritional supplements in improving glycolipid metabolism and endocrine function in polycystic ovary syndrome: a systematic review and network meta-analysis. PeerJ. 2023 Nov 13;11:e16410. doi: 10.7717/peerj.16410. eCollection 2023.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668517/', 'label': 'Efficacy of coenzyme Q10 supplementation on glucose metabolism, lipid profiles, and biomarkers of inflammation in women with polycystic ovary syndrome'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the effects of coenzyme Q10 supplementation on oxidative stress, inflammation and hyperandrogenism in women with polycystic ovary syndrome. The main questions it aims to answer are:\n\nDoes Coenzyme Q10 alter oxidative stress, inflammation and hyperandrogenism in women with Polycystic ovary syndrome.\n\nParticipants will take Coenzyme Q10 200mg, once daily for a period of 3 months. The participants will be reassessed after 12 weeks by measuring Malondialdehyde MDA, C-reactive protein CRP, Sex hormone binding globulin SHBG.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'biological females would be accepted because this condition effects ovaries that are present in biological females only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Married Patients that presented with anovulatory infertility due to PCOS.\n* Unmarried Patients that presented with symptoms due to PCOS\n* All patients should fulfill Rotterdam criteria for PCOS\n\nExclusion Criteria:\n\n* Male factor infertility ( oligospermia or aspermia)\n* Tubal factor infertility (abnormal hysterosalpingography)\n* Diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function\n* Autoimmune and Inflammatory disorders\n* Abnormal serum prolactin level\n* Smokers\n* Alcoholic beverage use\n* Use of anti diabetic, anti-obesity drugs, insulin or vitamin and mineral supplements'}, 'identificationModule': {'nctId': 'NCT06659406', 'acronym': 'PCOS', 'briefTitle': 'Effect of Coenzyme Q10 Administration on Polycystic Ovary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Faisalabad'}, 'officialTitle': 'The Effect of Coenzyme Q10 Supplementation on Oxidative Stress, Inflammation and Hyperandrogenism in Women with Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'Tuf/IRB/275/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CoQ-10 supplementation', 'description': 'The experimental arm will consist of fertile females diagnosed with polycystic ovary syndrome aged between 18 to 50 years. Patients with diabetes mellitus, thyroid dysfunction, cardiovascular diseases, impairment of hepatic and renal function, autoimmune and Inflammatory disorders will be excluded.', 'interventionNames': ['Dietary Supplement: Coenzyme Q10']}], 'interventions': [{'name': 'Coenzyme Q10', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ubiquinone'], 'description': 'Coenzyme Q10 will be given once daily, 200mg for the period of 3 months', 'armGroupLabels': ['CoQ-10 supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Dr Sadia Ijaz, FCPS Hematology', 'role': 'CONTACT', 'email': 'sadia.ijaz@tuf.edu.pk', 'phone': '+923037869990'}, {'name': 'Dr Sana Akram, FCPS PHYSIOLOGY', 'role': 'CONTACT', 'email': 'sana.akram1986@gmail.com', 'phone': '+923334577182'}, {'name': 'Hira Zahid, MBBS, Masters in Physiology', 'role': 'CONTACT'}], 'facility': 'Madinah Teaching Hospital', 'geoPoint': {'lat': 31.41554, 'lon': 73.08969}}], 'centralContacts': [{'name': 'hira zahid, MBBS, M.Phil.', 'role': 'CONTACT', 'email': 'drhirazahid@yahoo.com', 'phone': '+923237624565'}, {'name': 'Sana Akram, MBBS, FCPS', 'role': 'CONTACT', 'email': 'sana.akram1986@gmail.com', 'phone': '+923334577182'}], 'overallOfficials': [{'name': 'Sana Akram, MBBS, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Faisalabad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'patients data will not be shared because it is highly confidential document'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Faisalabad', 'class': 'OTHER'}, 'collaborators': [{'name': 'College of Physicians and Surgeons Pakistan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'hira zahid', 'investigatorAffiliation': 'University of Faisalabad'}}}}