Sinomenine Versus Glucocorticoid for Knee OA

Sponsor

Shanghai 6th People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05764304

Collaborator

(none)

328

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Sinomenine Drug: Glucocorticoid	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

328 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Therapeutic Evaluation of Treatment With Sinomenine Versus Glucocorticoid for Early Knee Osteoarthritis: A Prospective, Double-Blind, Randomized, Multicenter Clinical Trial

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Feb 27, 2025

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sinomenine	Drug: Sinomenine Participants will receive one intra-articular injection every 4 months
Active Comparator: Glucocorticoid	Drug: Glucocorticoid Participants will receive one intra-articular injection every 4 months

Arm

Intervention/Treatment

Experimental: Sinomenine

Drug: Sinomenine

Participants will receive one intra-articular injection every 4 months

Active Comparator: Glucocorticoid

Drug: Glucocorticoid

Participants will receive one intra-articular injection every 4 months

Outcome Measures

Primary Outcome Measures

total WOMAC score and tibial cartilage volume [24 months after the first injection]
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.

Secondary Outcome Measures

The Timed Up and Go and 20m walking time [24 months after the first injection]
24 months after the first injection (1) the change in time from baseline in The Timed Up and Go (TUG) test and whether sinomenine was noninferior to glucocorticoid, and (2) the change in time spent at 20m walking time from baseline was and whether sinomenine was noninferior to glucocorticoid.

Other Outcome Measures

Bone marrow lesion (BML) [12 and 24 months after the first injection]
12 and 24 months after the first injection, to evaluate bone marrow lesion (BML) size of patients and whether sinomenine was noninferior to glucocorticoid.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;
Inability to understand written and spoken Chinese.
Any history of mental and psychological illness.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai 6th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changqing Zhang, Principal Investigator, Shanghai 6th People's Hospital

ClinicalTrials.gov Identifier:

NCT05764304

Other Study ID Numbers:

2021-277

First Posted:

Mar 10, 2023

Last Update Posted:

Mar 10, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2023