Herbs of rich-Iodine for Graves’ Hyperthyroidism Trial (the HIGHT trial): a study protocol for a randomized, double-blind, placebo-controlled, multicentre clinical trial

BackgroundGraves' hyperthyroidism is one of the refractory diseases in endocrinology. Thionamides are known to be effective and its common side-effects are markedly reduced when starting with low dose. Iodine-rich Chinese herbal decoction (IRH) is a frequently prescribed Chinese herbal medicine in patients with Graves' hyperthyroidism. However, high quality clinical evidence is still very scarce, which made the Traditional Chinese Medical (TCM) management of Graves' hyperthyroidism remains controversial. The objective of this study is to prove that IRH might get faster and longer lasting remission and improved quality of life (QoL) in Graves' hyperthyroidism patients compared with methimazole (MMI) .Methods/designThis study is a randomized, double-blind, placebo-controlled and multicentre clinical trial. We will recruit a total of 240 participants with Graves' hyperthyroidism who have any common ATD-associated side-effects. They will be randomized (1:1:1) to receive (ⅰ) IRH plus MMI placebo, (ⅱ) IRH placebo plus MMI and (ⅲ) IRH plus MMI for 12 weeks. The primary outcome measures will be the serum free triiodothyronine (FT3), free thyroxine (FT4) levels and serum thyroid-stimulating hormone (TSH) level. Secondary outcome measures will include the level of thyroid stimulating hormone-receptor antibodies (TRAb), thyroid ultrasound (US) and Thyroid-specific Patient Reported Outcome(ThyPRO39).DiscussionThe outcomes of this study will provide new evidence for the efficacy and safety of IRH for the treatment of Graves' hyperthyroidism and will also guide physicians at clinics more clearly in prescribing IRH.Trial registration number:ChiCTR, ChiCTR2000032706. Registered 7 May 2020, http://www.chictr.org.cn

Effectiveness and Safety of Bushen Huoxue in Treatment of Premature Ovarian Insufficiency: study protocol for a randomised, double-blinded, placebo-controlled and multicentre clinical trial

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.