Clinical trial NCT05764304: Sinomenine Versus Glucocorticoid for Knee OA
Official title: Therapeutic Evaluation of Treatment With Sinomenine Versus Glucocorticoid for Early Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Osteoarthritis
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 328
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both glucocorticoid and sinomenine are widely used in the routine clinical treatment of osteoarthritis, but there is still a lack of high level of clinical evidence for the direct comparison of efficacy between the two drugs. This trial aims to evaluate whether intraarticular injection of sinomenine was noninferior to intraarticular injection of glucocorticoid for symptom relief in patients with early knee arthritis, and whether intraarticular injection of sinomenine was superior to intraarticular injection of glucocorticoid for changes in tibial cartilage volume (measured by mean thickness) from baseline compared with intraarticular injection of glucocorticoid. 326 people will participate in the study at 3 different research/medical institutions, with centres competing for inclusion. This trial was designed by random blind method. This trial will last for 2 years and participants will receive 6 injections every 4 months.


Eligibility criteria: Inclusion Criteria:

1. Age \> 40 and \<70.
2. Bilateral knee pain lasting for more than 6 months and most of the last month;
3. X-rays showed that Kellgren and Lawrence had grade 2 or 3 knee osteoarthritis.

Exclusion Criteria:

1. Kellgren and Lawrence Level 1 or 4.
2. Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space.
3. The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months.
4. Have had knee surgery or plan to have joint surgery on the affected knee.
5. Other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function.
6. Have a needle phobia.
7. Immunosuppression or acute infection is present.
8. Patients are allergic to the drugs involved in the study.
9. Have or have had cancer or tumours.
10. Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy.
11. History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides \>2.3mmol/L
12. Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers.
13. Pregnancy.
14. Body mass Index (BMI) \> 40 kg/m2.
15. Unable to attend all study appointments within 24 months;
16. Inability to understand written and spoken Chinese.
17. Any history of mental and psychological illness.

Primary outcomes:
measure: total WOMAC score and tibial cartilage volume
timeFrame: 24 months after the first injection
Secondary outcomes:
measure: The Timed Up and Go and 20m walking time
timeFrame: 24 months after the first injection
Other outcomes:
measure: Bone marrow lesion (BML)
timeFrame: 12 and 24 months after the first injection
Locations:
Study officials:
References: