Efficacy and Safety Comparisons of Lingshu Granule versus Decoction in Polycystic Ovary Syndrome Patients with Insulin Resistance: A Multicenter Randomized Controlled Dose-Finding Trial Protocol
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 200 participants or records.
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