A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder

Study Overview
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Brief Summary
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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
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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

Official Title
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A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder

Conditions
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Periarthritis

Intervention / Treatment
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* Drug: Sodium Hyaluronate
* Drug: Aerzhi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Signs and symptoms were repeated for 12 weeks or more at the time of signing informed consent (12 weeks or more) 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 Fully informed consent signed voluntarily informed consent Exclusion Criteria: 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 Patients who are not suitable for medical treatment (e.g. patients with surgical indications) Patients who received opioids before the first study of the drug 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) 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) Treatment of shoulder joint (bilateral or unilateral) with hyaluronic acid injection within 24 weeks before the first study of the drug It is diagnosed as rheumatic disease Patients unable to assess their clinical manifestations Skin disease or skin infection around the injection site can cause the risk of injection infection Severe heart disease, renal failure, hematologic diseases, or diabetes mellitus There is a history of hypersensitivity to any component in the research drug (IMP)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patient was diagnosed with periarthritis of shoulder
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Hyaluronate group<br>Treatment of periarthritis of shoulder with Sodium Hyaluronate | Drug: Sodium Hyaluronate<br>* Hyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form<br>|
| Active Comparator: Aerzhi group<br>Treatment of periarthritis of shoulder with Aerzhi | Drug: Aerzhi<br>* Sodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage<br>* Other names: Sodium Hyaluronate Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Pain Rating Scale（NRS） | At fifth weeks, subjects reported changes in NRS pain scores compared to baseline | Fifth weeks after medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events | The number of adverse events：Abnormal laboratory examination results，symptoms or diseases | Fifth weeks after medication |