补肾活血颗粒治疗卵巢早衰有效性和安全性的随机、双盲、安慰剂对照、多中心临床试验研究方案。
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.
机构信息
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
Department of Obstetrics and Gynecology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
出版信息
Trials. 2021 Dec 4;22(1):877. doi: 10.1186/s13063-021-05838-w.
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 .
简介
卵巢早衰（POI）严重影响育龄期妇女的生活质量、内分泌功能和生育能力。目前，POI 的激素替代治疗存在疗效低或副作用高的局限性。补肾活血法（BSHX）在缓解 POI 患者的临床症状和改善健康状况方面发挥着重要作用。本安慰剂对照、随机、双盲、多中心临床试验方案旨在评估 BSHX 治疗 POI 女性的有效性和安全性。
方法和设计
我们计划从中国 4 家参与医院招募 150 名 POI 女性患者。参与者将以 1:1 的比例随机接受口服 BSHX 或 BSHX 安慰剂治疗。所有参与者将接受 3 个月的治疗，并在 6 个月后进行随访。主要结局是根据总症状变化的问卷评分，即中文版绝经综合征生活质量量表（CMS）（Nie G, Yang H, Liu J, Zhao C, Wang X, Menopause 24(5):546-554, 2017）。所有参与者在干预前、随机分组后 3 个月和 6 个月时均进行 CMS 测量。其他测量包括血清性激素水平、抗苗勒管激素（AMH）水平、卵巢峰值收缩速度（PSV；cm/s）和窦卵泡计数（AFC）。在这项研究中，通过血清性激素水平的变化评估中药对激素的调节作用，包括血清雌二醇（E2）、黄体生成素（LH）和卵泡刺激素（FSH）。这些指标将在干预前和随机分组后 3 个月进行测量。
伦理与传播
本研究经江苏省中西医结合医院伦理委员会批准（2019LWKY014）。所有参与者在随机分组前均提供书面知情同意书。本研究结果将在学术会议和同行评议期刊上公布。
试验注册
ChiCTR1900028451。注册于 2019 年 12 月 22 日，网址：https://www.chictr.org.cn/index.aspx。
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