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Analysis of Advantageous Populations for Yiqi Xuanbi Formula in Treating Knee Osteoarthritis of Qi-Deficiency and Dampness-Obstruction Type: A Retrospective Cohort Study Based on Real-World Clinical Data

Analysis of Advantageous Populations for Yiqi Xuanbi Formula in Treating Knee Osteoarthritis of Qi-Deficiency and Dampness-Obstruction Type: A Retrospective Cohort Study Based on Real-World Clinical Data

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000354
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Interventions

Treatment Group:Administered Yiqi Xuanbi Formula combined with basic treatment
Control Group:Administered conventional Western medicine combined with basic treatment

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients who were treated at Wangjing Hospital, China Academy of Chinese Medical Sciences between September 2020 and December 2025, with a definite diagnosis of knee osteoarthritis (KOA) recorded in the electronic medical record (EMR) system; Patients whose medical records meet the Western medical diagnostic criteria for knee osteoarthritis (in accordance with the Guidelines for the Diagnosis and Treatment of Knee Osteoarthritis) and have complete and traceable diagnostic records; Patients with a clear documentation of "qi deficiency and dampness obstruction syndrome" or equivalent syndrome descriptions in previous TCM medical records, inpatient/outpatient progress notes; Patients with imaging data (X-ray) available during treatment that can determine the Kellgren-Lawrence (K-L) grading of KOA, with a grading of Grade I to III; Patients with at least one complete set of pre-treatment and post-treatment records of primary efficacy evaluation indicators, including VAS score, WOMAC score, or TCM syndrome score; Patients with complete clinical medical records that can meet the requirements for data extraction and analysis in this study.

Exclusion criteria

Exclusion criteria: Patients with a definite diagnosis of rheumatoid arthritis, gouty arthritis, ankylosing spondylitis, infectious arthritis, or other non-degenerative knee joint diseases as documented in medical records; Patients with previous imaging or progress notes indicating severe knee structural damage (e.g., marked varus/valgus deformity, severe flexion contracture) and who have been clearly assigned to a surgical treatment pathway; Patients with severe dysfunction of vital organs such as the heart, liver, or kidneys during treatment, which may significantly affect treatment selection or efficacy evaluation; Patients with missing key study variables in medical records (e.g., incomplete records of primary efficacy indicators or treatment regimens) that preclude valid statistical analysis.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (VAS);Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);TCM Syndrome Score;

Secondary

MeasureTime frame
Knee Circumference;Knee Range of MotionBlo o d;

Countries

China

Contacts

Public ContactCheng Ting

Wangjing Hospital, China Academy of Chinese Medical Sciences

wjyychengting@163.com15801221717

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026