Abstract
INTRODUCTION: Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age. Although multiple treatment strategies have been proposed, many patients still experience suboptimal outcomes. Our research team has developed the Lingshu formula, which is grounded in traditional Chinese medicine theory, focusing on kidney deficiency and phlegm dampness. Clinical and animal studies have demonstrated its efficacy in improving insulin resistance, regulating hormonal and lipid metabolism, and reducing obesity, which was non-inferior to metformin. However, Lingshu is traditionally prepared in formula decoction, with a complicated and time-consuming process. The granule preparations have offered the advantages of stable drug quality, convenient storage and administration, and high patient compliance. However, the efficacy, safety, and optimal dosage of the Lingshu formula granules compared to its traditional decoction in the treatment of PCOS patients with insulin resistance still require further investigation. Therefore, this study aims to determine whether the Lingshu formula granules are superior to the traditional decoction and to establish their optimal dosage. METHODS: We will conduct a multicenter, randomized, controlled clinical trial targeted to enroll 200 patients. Eligible participants will be randomly assigned, in a 1:1:1:1 ratio, to group A (low-dose Lingshu granules, -20% from standard dose), group B (medium-dose Lingshu granules, standard dose), group C (high-dose Lingshu granules, +20% from standard dose), or group D (Lingshu decoction). Treatment will last 90 days. The primary outcome is the insulin resistance index, and secondary outcomes include body mass index, waist-to-hip ratio, and laboratory tests, which will be recorded and compared across these four groups. In addition, variations in symptoms related to the Chinese traditional medicine and adverse events will also be documented and compared. DISCUSSION: The findings are expected to provide a scientific basis for the clinical application of the Lingshu formula granules in PCOS patients with insulin resistance and promote widespread use of traditional Chinese medicine.