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

Peking University

Status: Unknown

Conditions: Periarthritis

Treatments: Drug: Sodium Hyaluronate; Drug: Aerzhi

Study type: Interventional

Funder types: Other

Identifiers

NCT03365388

CSG-trail201703

Details and patient eligibility

About

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

Full 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

Enrollment: 260 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

260 participants in 2 patient groups

Sodium Hyaluronate group

Experimental group

Description:

Treatment of periarthritis of shoulder with Sodium Hyaluronate

Treatment:

Drug: Sodium Hyaluronate

Aerzhi group

Active Comparator group

Description:

Treatment of periarthritis of shoulder with Aerzhi

Treatment:

Drug: Aerzhi