What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Model-Guided Precision Acupuncture, Personalized Lifestyle Intervention, or Conventional Acupuncture. The registry lists allocation as randomized. This study is designed as a prospective, multicenter, parallel-group randomly assigned controlled trial to measure the effectiveness of a "precision acupuncture + personalized lifestyle" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS).
They plan to enroll about 210 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
MulticenterClinical Study of Intelligent and Precise Acupuncture and Lifestyle Interventions for Polycystic Ovary Syndrome Guided by Multimodal With Ocular Diagnosis
Interventions: Model-Guided Precision Acupuncture, Personalized Lifestyle Intervention, Conventional Acupuncture, Standard Lifestyle Intervention
Primary outcome (registry wording): HOMA-IR level after 12 weeks of treatment