Periarthritis
Conditions
Brief summary
Alge as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate
Detailed description
Aerzhi as a positive control drug, in patients with periarthritis of shoulder, in a double-blind, controlled manner to study the safety and treatment of Sodium Hyaluronate. Once a week, continuous treatment for 5 weeks
Interventions
DRUGSodium Hyaluronate
Hyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form
DRUGAerzhi
Sodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The evaluation of the subjects will be conducted by the blind researchers. The IMP administration of the subjects will be conducted by non blind researchers or legal staff authorized by the principal investigator (PI)
Intervention model description
The patient was diagnosed with periarthritis of shoulder
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Based on clinical symptoms and range of motion (ROM) limitation: abduction is not more than 135 degrees, external rotation is not more than 20 degrees or the maximum internal rotation arrives at the first lumbar spinous process (the tip of the patient can touch) to diagnose the patients with periarthritis of shoulder 2. Signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more) 3. At zeroth weeks, according to the pain assessment scale (NRS, range: 0-10), the subjects' self rating pain score was no less than 5 points 4. Fully informed consent signed voluntarily informed consent
Exclusion criteria
1. Lead to other diseases of shoulder disorders, such as acute rotator cuff tear, calcific tendinitis. If the diagnosis is necessary, the MRI scan is performed 2. Patients who are not suitable for medical treatment (e.g. patients with surgical indications) 3. Patients who received opioids before the first study of the drug 4. Patients who received the following or more treatment within 2 weeks before the first use of the drug(Bilateral or unilateral shoulder joint movement therapy/Treatment of periarthritis of shoulder with proprietary Chinese Medicine) 5. Patients who received the following or more treatment within 4 weeks before the first use of the drug(Corticosteroids were injected locally or bilaterally on either side of the shoulder or on the other side of the shoulder (bilateral or unilateral shoulder joint);Oral corticosteroids, suppositories or intravenous preparations for the treatment of glucocorticoids) 6. Treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug 7. It is diagnosed as rheumatic disease 8. Patients unable to assess their clinical manifestations 9. Skin disease or skin infection around the injection site can cause the risk of injection infection 10. Severe heart disease, renal failure, hematologic diseases, or diabetes mellitus 11. There is a history of hypersensitivity to any component in the research drug (IMP)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Pain Rating Scale（NRS） | Fifth weeks after medication | At fifth weeks, subjects reported changes in NRS pain scores compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of adverse events | Fifth weeks after medication | The number of adverse events：Abnormal laboratory examination results，symptoms or diseases |
Countries
China
Contacts
Primary ContactPeng Zhang, Doctor
Backup ContactYichong Zhang, Doctor
Outcome results
None listed