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

Not Applicable

• Conditions: Periarthritis
• Interventions: Drug: Sodium Hyaluronate; Drug: Aerzhi

• Registration Number: NCT03365388
• Lead Sponsor: Peking University People's Hospital

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

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-02
• Study First Submitted QC: 2017-12-06
• Last Update Submitted: 2017-12-06
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-04-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Hyaluronate group	Sodium Hyaluronate	Treatment of periarthritis of shoulder with Sodium Hyaluronate
Aerzhi group	Aerzhi	Treatment of periarthritis of shoulder with Aerzhi

Primary Outcome Measures

Name	Time	Method
Changes of Pain Rating Scale（NRS）	Fifth weeks after medication	At fifth weeks, subjects reported changes in NRS pain scores compared to baseline

Secondary Outcome Measures

Name	Time	Method
The number of adverse events	Fifth weeks after medication	The number of adverse events：Abnormal laboratory examination results，symptoms or diseases

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Peking, Beijing, China