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, randomised, double-blind, and multicentre 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 randomised in a 1:1 to receive oral BSHX or BSHX placebo. All participants will be treated for 3-month 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)1. The other measurements include serum sex hormone levels, anti-mullerian 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 was evaluated by the changes of serum sex hormone levels, which include serum estradiol (E2), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). 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 number ChiCTR1900028451.Registered 22 December 2019, www.chictr.org.
Improvement of health-related quality of life and adherence to treatment with calcipotriol-betamethasone dipropionate gel in patients with psoriasis vulgaris
