Department of Obstetrics and Gynecology, First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China.
BMJ Open. 2013 Oct 25;3(10):e003646. doi: 10.1136/bmjopen-2013-003646.
Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in reproductive-age women. Chinese herbal medicine has been used for the treatment of PCOS, but the evidence for its efficacy and safety is minimal. Tanshinones are a class of bioactive molecules isolated from Salvia miltiorrhiza, a commonly used herb in Traditional Chinese Medicine. This study aims to evaluate the efficacy of tanshinones on hyperandrogenism and quality of life in women with PCOS who do not attempt to conceive.
A total of 100 patients will be recruited and randomised into the tanshinone or placebo group. Tanshinone or placebo capsules will be taken orally for 12 weeks. The primary outcome parameter will be a change in plasma testosterone. Secondary end points will be changes in human chorionic gonadotropin-induced androgen response, insulin resistance, reproductive hormones, fasting lipid profiles, oral glucose tolerance test, quality of life and side effects.
Written informed consent will be obtained from each participant at the time of enrolling in the study. The trial has been approved by the Ethics Committee of First Affiliated Hospital of Heilongjiang University of Chinese Medicine. Results will be disseminated through a publicly accessible website.
The study has been registered at the Chinese Clinical Trials Registry (ChiCTR-TRC-12002973) and at clinicaltrials.gov (NCT 01452477).
多囊卵巢综合征（PCOS）是生育期妇女最常见的内分泌疾病之一。中药已被用于治疗 PCOS，但疗效和安全性的证据很少。丹参酮是从丹参中分离出的一类生物活性分子，丹参是中药中的常用草药。本研究旨在评估丹参酮对不尝试怀孕的 PCOS 妇女高雄激素血症和生活质量的疗效。
共招募 100 名患者，随机分为丹参酮或安慰剂组。丹参酮或安慰剂胶囊口服 12 周。主要结局参数将是血浆睾酮的变化。次要终点将是绒毛膜促性腺激素诱导的雄激素反应、胰岛素抵抗、生殖激素、空腹血脂谱、口服葡萄糖耐量试验、生活质量和副作用的变化。
在入组时，将从每位参与者处获得书面知情同意。该试验已获得黑龙江中医药大学第一附属医院伦理委员会的批准。结果将通过一个公开的网站传播。
该研究已在中国临床试验注册中心（ChiCTR-TRC-12002973）和临床试验.gov（NCT 01452477）注册。
