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Efficacy and Safety of the Chinese Herbal Compound TJAOA101 in Treating Diminished Ovarian Reserve: A Protocol for Multicenter, Prospective, and Pre-Post Study

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收录情况: ◇ SCIE ◇ 卓越:梯队期刊

单位: [1]National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan 430030, China [2]Key Laboratory of Cancer Invasion and Metastasis,Ministry of Education,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [3]Department of Obstetrics and Gynecology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [4]Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [5]Department of Integrated Traditional Chinese and Western Medicine,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [6]Department of Obstetrics and Gynecology, the Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450015, China [7]Department of Obstetrics and Gynecology, Changsha Hospital for Maternal and Child Health Care of Hunan Normal University, Changsha 410007, China [8]Department of Obstetrics and Gynecology, Xiangyang Central Hospital, Hubei University of Arts and Science, Xiangyang 441057, China [9]Department of Obstetrics and Gynecology, Maternal and Child Health Hospital of Jiangxi Province, Nanchang 330006, China [10]Department of Obstetrics and Gynecology, Renhe Hospital Affiliated to Three Gorges University, Yichang 443001, China
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关键词: diminished ovarian reserve Chinese herbs TJAOA101 multicenter study study protocol

摘要:
Diminished ovarian reserve (DOR) can lead to early menopause, poor fecundity, and an increased risk of disorders such as osteoporosis, cardiovascular disease, and cognitive impairment, seriously affecting the physical and mental health of women. There is still no safe and effective strategy or method to combat DOR. We have developed a novel Chinese herbal formula, Tongji anti-ovarian aging 101 (TJAOA101), to treat DOR. However, its safety and efficacy need to be further validated.In this prospective and pre-post clinical trial, 100 eligible patients aged 18-45 diagnosed with DOR will be recruited. All participants receive TJAOA101 twice a day for 3 months. Then, comparisons before and after treatment will be analyzed, and the outcomes, including anti-mullerian hormone (AMH) and follicle-stimulating hormone (FSH) levels and the antral follicle count (AFC), the recovery rate of menopause, and the Kupperman index (KMI), will be assessed at baseline, every month during medication (the intervention period), and 1, 3 months after medication (the follow-up period). Assessments for adverse events will be performed during the intervention and follow-up periods.A multicenter, prospective study will be conducted to further confirm the safety and efficacy of TJAOA101 in treating DOR and to provide new therapeutic strategies for improving the quality of life in DOR patients.© 2023. Huazhong University of Science and Technology.

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出版当年[2022]版:
大类 | 3 区 医学
小类 | 4 区 医学:研究与实验
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大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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Q4 MEDICINE, RESEARCH & EXPERIMENTAL
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Q3 MEDICINE, RESEARCH & EXPERIMENTAL

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第一作者单位: [1]National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan 430030, China [2]Key Laboratory of Cancer Invasion and Metastasis,Ministry of Education,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [3]Department of Obstetrics and Gynecology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China
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通讯机构: [1]National Clinical Research Center for Obstetrical and Gynecological Diseases, Wuhan 430030, China [2]Key Laboratory of Cancer Invasion and Metastasis,Ministry of Education,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China [3]Department of Obstetrics and Gynecology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China
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