Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-30 @ 2:32 PM
Study NCT ID:
NCT05465135
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2022-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dihydroartemisinin in PCOS
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': 'C039060', 'term': 'artenimol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '20 participants with PCOS receive dihydroartemisinin for 3 months'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2022-07-10', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery of regular menses by questionnaire', 'timeFrame': '12 weeks', 'description': 'Periodical vaginal bleeding by questionnaire'}, {'measure': 'Bilateral ovary volume', 'timeFrame': '12 weeks', 'description': 'Length, width and height of bilateral ovaries measured by B type ultrasound'}, {'measure': 'Number of immature follicles', 'timeFrame': '12 weeks', 'description': 'Total number of follicles with diameters \\<10 mm measured by B type ultrasound'}, {'measure': 'Serum testosterone levels', 'timeFrame': '12 weeks', 'description': 'Measurement of serum total testosterone'}], 'secondaryOutcomes': [{'measure': 'Serum anti-Mullerian hormone', 'timeFrame': '12 weeks', 'description': 'Measurement of serum AMH'}, {'measure': 'Sex hormone binding globulin (SHBG)', 'timeFrame': '12 weeks', 'description': 'Measurement of serum SHBG'}, {'measure': 'Serum dehydroepiandrosterone sulfate', 'timeFrame': '12 weeks after drug intervention', 'description': 'Measurement of serum DHEA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': "Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin also has some significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigators' previous studies discovered that Artemisinin dramatically reduced serum androgen levels and improved poly-cystic ovary syndrome(PCOS) in animals. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects.", 'detailedDescription': "Polycystic ovary syndrome (PCOS) is a common reproductive endocrine metabolic disorder caused by a combination of genetic and environmental factors. The pathogenesis of PCOS remains unclear. Artemisinin has been widely used as a first-line antimalarial drug in routine clinical practice. In recent years, it has been reported that Artemisinin has significant anti-inflammatory, anti-tumor and immune-modulating effects. The investigator's previous studies found that artemisinin and its derivatives could significantly promote uncoupling protein 1 (UCP1) transcription and the conversion of white fat to brown fat. Artemisinin derivatives upregulated the levels of genes critical for brown fat differentiation and function, accompanied by enhanced mitochondrial biosynthesis, demonstrating their potential to promote white fat browning and improve metabolism in rodent models. The investigators also observed that androgen levels in drug-induced PCOS rats were reduced, when treated with artemether analogs for prophylactic and therapeutic purposes, respectively. It is believed that the two core mechanisms in the pathogenesis of PCOS are excessive androgen synthesis and insulin resistance. Preliminary study by the investigators found that artemisinin derivatives are capable of reducing both serum androgen levels and improving insulin resistance, two clinical characteristics of PCOS. Thus artemisinin derivatives has the potential effect to alleviate PCOS symptoms and control or even reverse the disease progression. The current study aims to investigate the effect of artemisinin on improving PCOS and serum androgen levels in PCOS subjects."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI 23-30kg/M2\n* No plan for pregnancy in the coming 6 months\n* Newly diagnosed PCOS, or PCOS without any medication for the past three months.\n* Patients should meet all the three following criteria:\n\n 1. Oligomenorrhea or amenorrhea: Oligomenorrhea is defined as more than 35 days between menstrual periods and less than 8 menstrual bleedings in the past year; amenorrhea is defined as more than 90 days between two menstrual bleedings.\n 2. Polycystic ovaries: ≥12 follicles in both ovaries (diameter\\<10mm), confirmed by ultrasound.\n 3. Elevated androgen levels: testosterone\\>1.67 nmol/L.\n\nExclusion Criteria:\n\n* Previously treated with steroids or other medications for PCOS in the past 3 months.\n* Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc.\n* Pregnancy.\n* Patients with other serious diseases affecting heart, liver, kidney, or other major organs.\n* Patients with any type of cancer."}, 'identificationModule': {'nctId': 'NCT05465135', 'briefTitle': 'The Effect of Dihydroartemisinin in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'The Evaluation of the Effect of Dihydroartemisinin in Patients With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'B2020-115R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dihydroartemisinin Group', 'description': 'The subjects take Dihydroartemisinin, 40mg tid for 12 weeks', 'interventionNames': ['Drug: Dihydroartemisinin']}], 'interventions': [{'name': 'Dihydroartemisinin', 'type': 'DRUG', 'description': 'Dihydroartemisinin 40mg three times a day for 12 consecutive weeks.', 'armGroupLabels': ['Dihydroartemisinin Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaoying Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xiaoying Li', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}