Sinomenine Versus Glucocorticoid for Knee OA

NCT ID: NCT05764304

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-03-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sinomenine

Group Type: EXPERIMENTAL

Sinomenine

Intervention Type: DRUG

Participants will receive one intra-articular injection every 4 months

Glucocorticoid

Group Type: ACTIVE_COMPARATOR

Glucocorticoid

Intervention Type: DRUG

Participants will receive one intra-articular injection every 4 months

Interventions

Sinomenine

Participants will receive one intra-articular injection every 4 months

Intervention Type: DRUG

Glucocorticoid

Participants will receive one intra-articular injection every 4 months

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Changqing Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2021-277

Identifier Type: -

Identifier Source: org_study_id