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Biqi Capsule's clinical efficacy and radiographic evaluation in the treatment of knee osteoarthritis with bone marrow edema

Biqi Capsule's clinical efficacy and radiographic evaluation in the treatment of knee osteoarthritis with bone marrow edema

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076690
Enrollment
Unknown
Registered
2023-10-16
Start date
2023-02-10
Completion date
Unknown
Last updated
2023-10-22

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

Conditions

Knee osteoarthritis with bone marrow edema

Interventions

Control group:Take etoricoxib tablets (Ankangxin, produced by Hangzhou Merck Sharp & Dohme Pharmaceutical Co., Ltd, State Drug Permit J20130158, specification 0.06g per tablet), 1 tablet each time, on
Test group:Take Biqi capsule (Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd, State Drug Permit Z10910026, specification 0.3 g per capsule), 4 capsules each time, 3 times a day, for 8 weeks.

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? In Western medicine, the diagnosis of KOA meets the diagnostic criteria of the Osteoarthritis Diagnostic and Treatment Guidelines (2021 edition), and the K/L stage does not exceed stage 3; In Chinese medicine, the diagnosis of "Gu Bi" is in line with the diagnostic criteria of the Diagnostic and Therapeutic Efficacy Criteria for Chinese Medicine Diseases ? Knee MRI shows clear signs of BME: diffuse high signal in the T2 image below the medial and lateral femoral condyles or tibial plateau; The traditional Chinese medicine syndrome differentiation types are: liver and kidney deficiency, dampness and obstruction; ? The patient plans not to perform surgical treatment within 2 months; ? The medical record is well documented; ? Patients are middle-aged or elderly patients (50-75 years old); ? Voluntary participation in the study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: ? Diagnosed with rheumatoid arthritis, Charcot's arthropathy and other joint diseases; ? Those with secondary KOA caused by various pathological factors such as trauma, infection and suppuration; ? Those with history of drug allergy, intolerance or refusal to take drugs; ? Those with knee deformity or bone defects; ? Those with mental illness.

Design outcomes

Primary

MeasureTime frame
Pain VAS score;—

Secondary

MeasureTime frame
Knee WOMAC score;Volume of bone marrow edema;WORMS score for bone marrow oedema;Peripheral blood inflammation indicators NLR, LMR;—

Countries

China

Contacts

Public ContactYongming Huang

Guangdong Provincial Hospital of Chinese Medicine

huang163huang@163.com+86 136 6000 3369

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026