Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol
Abstract Background Premature ovarian insufficiency (POI), a condition impacting women under 40, is rising globally, posing significant risks to fertility, bone health, and cardiovascular function. Conventional hormone replacement therapy (HRT) alleviates symptoms but fails to restore ovarian functi...
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BMC
2025-02-01
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| Series: | BMC Complementary Medicine and Therapies |
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| Online Access: | https://doi.org/10.1186/s12906-025-04803-3 |
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| author | Yin Peng Jian Liu Yang Li Guangning Nie Fangping Cheng Daning Feng Qiaolin Du Jian Huang Hongyan Yang |
| author_facet | Yin Peng Jian Liu Yang Li Guangning Nie Fangping Cheng Daning Feng Qiaolin Du Jian Huang Hongyan Yang |
| author_sort | Yin Peng |
| collection | DOAJ |
| description | Abstract Background Premature ovarian insufficiency (POI), a condition impacting women under 40, is rising globally, posing significant risks to fertility, bone health, and cardiovascular function. Conventional hormone replacement therapy (HRT) alleviates symptoms but fails to restore ovarian function. Our prior studies have demonstrated that the Huyang Yangkun (HYYK) formula effectively supports menstrual cycle frequency and alleviates menopause-related symptoms in POI patients. This study aims to evaluate the efficacy and safety of the HYYK formula, a traditional Chinese medicine (TCM) approach, in enhancing residual follicle activity in POI patients. Methods This multicenter, randomized, double-blind, placebo-controlled trial will enroll 102 women with POI, who will be randomly assigned to receive either the HYYK formula or a placebo for 24 weeks. Primary outcomes will be assessed through Hoogland and Skouby scores (indicative of residual follicle activity) and menstrual cycle regularity. Secondary outcomes include hormone levels (AMH, FSH, LH, E2), ovarian volume, antral follicle count, and clinical symptom scales, such as the Greene Scale and the Female Sexual Function Index. Safety assessments will involve routine physical exams and adverse event monitoring. Discussion This is the first multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy of TCM in stimulating residual follicle recovery in POI patients. The trial rigorously investigates the potential of the HYYK formula as a therapeutic alternative for POI, aiming to deliver high-quality evidence that supports the use of TCM in POI management. This study will concentrate on stimulating residual follicle development in POI patients, offering a viable approach to delaying ovarian decline and generating compelling clinical evidence. Trial registration Chinese Clinical Trials.gov ChiCTR2100049604 Registered on August 6, 2021 ( http://www.chictr.org.cn ). |
| format | Article |
| id | doaj-art-dadca8a92bc34d3a9c0436d6fbf2718f |
| institution | OA Journals |
| issn | 2662-7671 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
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| series | BMC Complementary Medicine and Therapies |
| spelling | doaj-art-dadca8a92bc34d3a9c0436d6fbf2718f2025-08-20T02:13:14ZengBMCBMC Complementary Medicine and Therapies2662-76712025-02-012511910.1186/s12906-025-04803-3Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocolYin Peng0Jian Liu1Yang Li2Guangning Nie3Fangping Cheng4Daning Feng5Qiaolin Du6Jian Huang7Hongyan Yang8The Second Clinical Medical College, Guangzhou University of Chinese MedicineDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese MedicineThe Second Clinical Medical College, Guangzhou University of Chinese MedicineDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese MedicineDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese MedicineDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese MedicineDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese MedicineDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese MedicineDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese MedicineAbstract Background Premature ovarian insufficiency (POI), a condition impacting women under 40, is rising globally, posing significant risks to fertility, bone health, and cardiovascular function. Conventional hormone replacement therapy (HRT) alleviates symptoms but fails to restore ovarian function. Our prior studies have demonstrated that the Huyang Yangkun (HYYK) formula effectively supports menstrual cycle frequency and alleviates menopause-related symptoms in POI patients. This study aims to evaluate the efficacy and safety of the HYYK formula, a traditional Chinese medicine (TCM) approach, in enhancing residual follicle activity in POI patients. Methods This multicenter, randomized, double-blind, placebo-controlled trial will enroll 102 women with POI, who will be randomly assigned to receive either the HYYK formula or a placebo for 24 weeks. Primary outcomes will be assessed through Hoogland and Skouby scores (indicative of residual follicle activity) and menstrual cycle regularity. Secondary outcomes include hormone levels (AMH, FSH, LH, E2), ovarian volume, antral follicle count, and clinical symptom scales, such as the Greene Scale and the Female Sexual Function Index. Safety assessments will involve routine physical exams and adverse event monitoring. Discussion This is the first multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy of TCM in stimulating residual follicle recovery in POI patients. The trial rigorously investigates the potential of the HYYK formula as a therapeutic alternative for POI, aiming to deliver high-quality evidence that supports the use of TCM in POI management. This study will concentrate on stimulating residual follicle development in POI patients, offering a viable approach to delaying ovarian decline and generating compelling clinical evidence. Trial registration Chinese Clinical Trials.gov ChiCTR2100049604 Registered on August 6, 2021 ( http://www.chictr.org.cn ).https://doi.org/10.1186/s12906-025-04803-3Premature ovarian insufficiency (POI)Traditional Chinese medicine (TCM)Residual follicleRandomized controlled trial |
| spellingShingle | Yin Peng Jian Liu Yang Li Guangning Nie Fangping Cheng Daning Feng Qiaolin Du Jian Huang Hongyan Yang Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol BMC Complementary Medicine and Therapies Premature ovarian insufficiency (POI) Traditional Chinese medicine (TCM) Residual follicle Randomized controlled trial |
| title | Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol |
| title_full | Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol |
| title_fullStr | Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol |
| title_full_unstemmed | Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol |
| title_short | Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol |
| title_sort | efficacy and safety of hyyk formula for residual follicle revival in premature ovarian insufficiency a multicenter randomized double blind placebo controlled trial protocol |
| topic | Premature ovarian insufficiency (POI) Traditional Chinese medicine (TCM) Residual follicle Randomized controlled trial |
| url | https://doi.org/10.1186/s12906-025-04803-3 |
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