Suspended
A Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
What is being tested
Sodium Hyaluronate
+ Aerzhi
Drug
Who is being recruted
Arthritis+2
+ Bursitis
+ Joint Diseases
From 35 to 80 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: April 2018
Summary
Principal SponsorPeking University People's Hospital
Study ContactPeng Zhang, DoctorMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2018
Actual date on which the first participant was enrolled.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 TitleA Validation Study of Sodium Hyaluronate in Patients With Periarthritis of Shoulder
Principal SponsorPeking University People's Hospital
Study ContactPeng Zhang, DoctorMore contacts
Last updated: January 27, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
260 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 35 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ArthritisBursitisJoint DiseasesMusculoskeletal DiseasesPeriarthritis
Criteria
4 inclusion criteria required to participate
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
11 exclusion criteria prevent from participating
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)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalTreatment of periarthritis of shoulder with Sodium Hyaluronate
Group II
Active ComparatorTreatment of periarthritis of shoulder with Aerzhi
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Peking University People's Hospital
Beijing, ChinaOpen Peking University People's Hospital in Google MapsSuspendedOne Study Center