Sinomenine Versus Glucocorticoid for Knee OA

NCT05764304 | Unknown Phase 3 DMC

• 1 other identifier: 2021-277
• Study Type: interventional
• Target: 328
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• total WOMAC score and tibial cartilage volume

  24 months after the first injection (1) the change in the total WOMAC score from baseline and whether sinomenine was noninferior to glucocorticoid, and (2) the change in tibial cartilage volume from baseline (on average thickness in mm) and whether sinomenine was noninferior to glucocorticoid.

  24 months after the first injection

Secondary Outcomes (1)

• The Timed Up and Go and 20m walking time

  24 months after the first injection

Other Outcomes (1)

• Bone marrow lesion (BML)

  12 and 24 months after the first injection

Study Arms (2)

Sinomenine

EXPERIMENTAL

Drug: Sinomenine

Glucocorticoid

ACTIVE COMPARATOR

Drug: Glucocorticoid

Interventions

Sinomenine DRUG

Participants will receive one intra-articular injection every 4 months

Sinomenine

Glucocorticoid DRUG

Participants will receive one intra-articular injection every 4 months

Glucocorticoid

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Kellgren and Lawrence Level 1 or 4.
• Radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space.
• The affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months.
• Have had knee surgery or plan to have joint surgery on the affected knee.
• 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.
• Have a needle phobia.
• Immunosuppression or acute infection is present.
• Patients are allergic to the drugs involved in the study.
• Have or have had cancer or tumours.
• Have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy.
• History of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/L and triglycerides \>2.3mmol/L
• Have any other medical conditions that do not participate in the study, including contraindications to MRI, such as pacemakers.
• Pregnancy.
• Body mass Index (BMI) \> 40 kg/m2.
• Unable to attend all study appointments within 24 months;

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Related Publications (1)

• Zhang X, Lin Z, Lv M, Lu C, Hu B, Yu W, Wang Z, Liu X, Zhang C, Wu D, He Y. Cartilage organoids bridging bench to bedside: A steroid-free strategy for early osteoarthritis repair. Mater Today Bio. 2025 Dec 21;36:102688. doi: 10.1016/j.mtbio.2025.102688. eCollection 2026 Feb.

  PMID: 41560786 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

sinomenine; Glucocorticoids

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 10, 2023
• Study Start: February 28, 2023
• Primary Completion: February 27, 2025
• Study Completion: March 31, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03