Status:
UNKNOWN
A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
Lead Sponsor:
Peking University People's Hospital
Conditions:
Periarthritis
Eligibility:
All Genders
35-80 years
Phase:
NA
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03365388
Start Date
April 1 2018
End Date
April 1 2020
Last Update
December 7 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044