Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial

Abstract Introduction Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX...

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Autores principales:	Ying Cao, Peijuan-Wang, Yan Lu, Yue Chen, Si Chen, Weibo-Zhao
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Chinese herbal medicine Premature ovarian insufficiency Bushen Huoxue Clinical trial protocol Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/367330131c7e4217836e2b545bf6044f
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spelling	oai:doaj.org-article:367330131c7e4217836e2b545bf6044f2021-12-05T12:20:08ZEffectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial10.1186/s13063-021-05838-w1745-6215https://doaj.org/article/367330131c7e4217836e2b545bf6044f2021-12-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05838-whttps://doaj.org/toc/1745-6215Abstract Introduction Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomized, double-blind, and multicenter clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI. Methods and design We plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomized in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3 months and will be followed up for another 3 month. The primary outcome is questionnaire scores based on the changes in the total symptoms, which is the Chinese version of the Menopause-Specific Quality of Life (CMS) (Nie G, Yang H, Liu J, Zhao C, Wang X, Menopause 24(5):546–554, 2017). CMS will be measured before the intervention, at 3 months and 6 months after randomization for all participants. The other measurements include serum sex hormone levels, anti-Müllerian hormone (AMH) levels, ovarian peak systolic velocity (PSV; cm/s), and antral follicle count (AFC). In this study, the regulatory effects of traditional Chinese medicine on hormones were evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). These indicators will be measured before intervention and at 3 months after randomization. Ethics and dissemination This study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals. Trial registration ChiCTR1900028451. Registered on 22 December 2019, https://www.chictr.org.cn/index.aspx .Ying CaoPeijuan-WangYan LuYue ChenSi ChenWeibo-ZhaoBMCarticleChinese herbal medicinePremature ovarian insufficiencyBushen HuoxueClinical trial protocolMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Chinese herbal medicine Premature ovarian insufficiency Bushen Huoxue Clinical trial protocol Medicine (General) R5-920
spellingShingle	Chinese herbal medicine Premature ovarian insufficiency Bushen Huoxue Clinical trial protocol Medicine (General) R5-920 Ying Cao Peijuan-Wang Yan Lu Yue Chen Si Chen Weibo-Zhao Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
description	Abstract Introduction Premature ovarian insufficiency (POI) seriously affects the quality of life, endocrine function, and fertility of women of childbearing age. Currently, hormone replacement therapy for POI has some limitations, either with low efficacies or high side effects. Bushen Huoxue (BSHX) plays an important role in alleviating clinical symptoms and improving health status of POI patients. This placebo-controlled, randomized, double-blind, and multicenter clinical trial protocol aims to evaluate the effectiveness and safety of BSHX in women with POI. Methods and design We plan to recruit 150 women with POI from four participating hospitals in China. Participants will be randomized in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3 months and will be followed up for another 3 month. The primary outcome is questionnaire scores based on the changes in the total symptoms, which is the Chinese version of the Menopause-Specific Quality of Life (CMS) (Nie G, Yang H, Liu J, Zhao C, Wang X, Menopause 24(5):546–554, 2017). CMS will be measured before the intervention, at 3 months and 6 months after randomization for all participants. The other measurements include serum sex hormone levels, anti-Müllerian hormone (AMH) levels, ovarian peak systolic velocity (PSV; cm/s), and antral follicle count (AFC). In this study, the regulatory effects of traditional Chinese medicine on hormones were evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). These indicators will be measured before intervention and at 3 months after randomization. Ethics and dissemination This study was approved by the Research Ethics Committee of Jiangsu Province Hospital on Integration of Chinese and Western Medicine (2019LWKY014). All participants will provide written informed consent prior to randomization. The results of this research will be presented to academic conferences and peer-reviewed journals. Trial registration ChiCTR1900028451. Registered on 22 December 2019, https://www.chictr.org.cn/index.aspx .
format	article
author	Ying Cao Peijuan-Wang Yan Lu Yue Chen Si Chen Weibo-Zhao
author_facet	Ying Cao Peijuan-Wang Yan Lu Yue Chen Si Chen Weibo-Zhao
author_sort	Ying Cao
title	Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
title_short	Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
title_full	Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
title_fullStr	Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
title_full_unstemmed	Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
title_sort	effectiveness and safety of bushen huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/367330131c7e4217836e2b545bf6044f
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Effectiveness and safety of Bushen Huoxue granules in treatment of premature ovarian insufficiency: study protocol for a randomized, double-blinded, placebo-controlled, and multicenter clinical trial

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