Efficacy of Bushen Huatan Decoction combined with Baduanjin in the treatment of polycystic ovary syndrome with insulin resistance (IR-PCOS), kidney deficiency and phlegm dampness: study protocol for a randomized controlled trial
Abstract
Background: Polycystic ovary syndrome (PCOS) is a common reproductive endocrine disease in women. Insulin resistance (IR) has emerged as a central contributor to the pathogenesis of this disease. According to traditional Chinese medicine (TCM), kidney deficiency is the main syndrome of PCOS. The deficiency of the kidney cannot vaporize water-dampness, and the retention of water-dampness accumulates into phlegm dampness stagnation, resulting in visceral dysfunction and metabolic disorder. TCM involving syndrome differentiation and treatment is widely used to adjust women's menstrual cycles. Our patented formula Bushen Huatan Decoction (BSHTD) has been proven to be effective in the clinical treatment of IR-PCOS. Baduanjin also plays an important role in improving metabolic syndrome through lifestyle intervention. This study investigates the clinical efficacy of Bushen Huatan Decoction combined with Baduanjin in IR-PCOS, to form a specific TCM-behaviour intervention plan in the treatment of IR-PCOS.
Methods/design: This is a randomized controlled trial involving 190 participants diagnosed with IR-PCOS. All participants will be randomly allocated into 5 groups: group A will receive metformin; group B, BSHTD; group C, Baduanjin; group D, BSHTD combined with metformin; and group E, BSHTD combined with Baduanjin. One course of treatment lasts 3 months, a total of two courses. The primary outcomes are changes in the homeostatic model assessment of insulin resistance (HOMA-IR) and…
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: 190 participants or records.
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