Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Clinical Trial on the Efficacy and Safety of Yunnan Baiyao Capsule in Improving Functional Disorders of Osteoporotic Vertebral Compression Fractures

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Experimental group:Basic treatment+Yunnan Baiyao capsules (0.25g/capsule);Control group:Basic treatment+Yunnan Baiyao Capsule Simulant; CONDITION: Osteoporotic vertebral compression fracture PRIMARY OUTCOME: Changes in Oswestry Disability Index Score from Baseline at Week 12 After Surgery; SECONDARY OUTCOME: Changes in Quality of Life Scores (EQ‐5D‐5L) at Various Visit Points Compared to Baseline;Changes in Oswestry Disability Inde Xscores compared to baseline on postoperative day 3 and week 4;Changes in Visual Analog Scores of Lower Back Pain at Various Visit Points Compared to Baseline;Changes in bone metabolism markers compared to baseline at postoperative weeks 4 and 12;Use of emergency analgesics during treatment;Changes in bone density compared to baseline at week 12 after surgery; INCLUSION CRITERIA: 1. Age between 50 and 75 years old (inclusive), any gender; 2. Diagnosed by imaging (X‐ray, CT, or MRI) with a single‐segment (thoracic T10 to lumbar L3), recent (from symptom onset to randomization <= 8 weeks) osteoporotic vertebral compression fracture (OVCF) in the thoracic or lumbar spine; 3. Successfully underwent single‐segment percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP) treatment ("success" is defined as: surgery completed smoothly without serious intraoperative complications leading to early withdrawal, such as symptomatic cement leakage, pulmonary embolism, etc.); 4. Meets the diagnostic criteria for primary osteoporosis: bone mineral density of the lumbar spine (L1‐L4) T‐score <= ‐2.5 as measured by dual‐energy X‐ray absorptiometry, or T‐score <= ‐1.0 with a history of fragility fractures; 5. Liver and kidney functions meet the following requirements: (1) Liver function: Alanine aminotransferase (ALT) and Aspartate a
Epistemonikos ID: 1b4aba59d2e071ae3e1854d72db697924d826c5a
First added on: Oct 08, 2026