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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Hyaluronate group | Experimental | Treatment of periarthritis of shoulder with Sodium Hyaluronate |
|
| Aerzhi group | Active Comparator | Treatment of periarthritis of shoulder with Aerzhi |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate | Drug | Hyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Zhang, Doctor | Contact | 08601088326550 | 52956255@qq.com | |
| Yichong Zhang, Doctor | Contact | 08601088326550 | zhangyichong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Peixun Zhang, Doctor | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Yamamoto M. Sugawara S. Tsukamoto Y. Motegi M. Iwata H. Ryu J. et al. Clinical Evaluation of high molecule weight hyaluronate (NRD101) on osteoarthritis of the knee: a phase III comparative clinical study with ARTZⓇ as a clinical drug. Jpn Pharmacol Ther 1994;22:319-47. | ||
| Background | Kurokawa T, Oda H, Mikami Y, Katsumoto H, Clinical Evaluation of high Molecule Weight Sodium Hyaluronate (NRD101) on osteoarthritis of the knee: phase III long-term clinical study. Jpn Pharmacol Ther 1994;22:267-88. | ||
| Background | Yamamoto R, Tabata S, Mikasa M, Takagishi K, Clinical evaluation of high molecule sodium hyaluronate (NRD101) on periarthritis scapulohumeralis. Jpn Pharmacol Ther 1993;21:267-80. | ||
| Background | Yamamoto R, Tabata S, Mikasa M, Takagishi K, Nakajima M, Dose-range finding study of high molecule weight sodium hyaluronate (NRD101) on periarthritis scapulohumeralis: a multi-center, late phase II clinical study. Jpn Pharmacol Ther 1994;22:351-74. | ||
| Background | Yamamoto R, Tabata S, Mikasa M, Takagishi K, Nakajima M, Phase 3 comperative clinical study of high molecular weight sodium hyaluronate (NRD101) with ARTZⓇ on periarthritis scapulohumeralis. Jpn Pharmacol Ther 1994;22:289-317. | ||
| Background | Tanaka S, Sohen S, Yamamoto M, Komatsubara Y, Sugawara S, Matsubara T, Additional analysis for a multi-center phase II clinical study of high molecule hyaluronic acid (NRD101) on rheumatoid arthritis. Clinical rheumatology and related research 2000:12: 157-78. |
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| ID | Term |
|---|---|
| D010489 | Periarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D002062 | Bursitis |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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The patient was diagnosed with periarthritis of shoulder
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The evaluation of the subjects will be conducted by the blind researchers. The IMP administration of the subjects will be conducted by non blind researchers or legal staff authorized by the principal investigator (PI)
| Aerzhi | Drug | Sodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage |
|
|
| Background | Tanaka S, Sohen S, Yamamoto M, Komatsubara Y, Sugawara S, Matsubara T, et al. Additional analysis for a multi-center phase III comparative clinical study of high molecular hyaluronic acid (NRD101) on rheumatoid arthritis. Clinical rheumatology and related research 2000;12: 179-204 |
| Background | Tanaka S, Sohen S, Yamamoto M, Komatsubara Y, Sugawara S, Matsubara T, Additional analysis for a multi-center, long-term clinical study of high molecule weight hyaluronic acid (NRD101) on rheumatoid arthritis. Clinical rheumatology and related research 2000;12:213-40. |
| 20170770 | Background | Zhang W, Nuki G, Moskowitz RW, Abramson S, Altman RD, Arden NK, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis: part III: Changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010 Apr;18(4):476-99. doi: 10.1016/j.joca.2010.01.013. Epub 2010 Feb 11. |