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| Name | Class |
|---|---|
| Wangjing Hospital, China Academy of Chinese Medical Sciences | OTHER |
| The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine | UNKNOWN |
| People's Hospital of Anshun City of Guizhou Province |
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Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis.
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guli capsule | Experimental | Guli capsule, the tested drug of this study |
|
| Kangguzengsheng capsule | Active Comparator | Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guli capsule | Drug | Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Visual Analog Scale | 4 weeks | |
| Number of Participants with Adverse Events as a Measure of Safety | 4 weeks |
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Inclusion Criteria:
Ages between 40 and 70 years, both gender
Kellgren and Lawrence grades of I to III;
The subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
Meet the following clinical and radiological criteria for diagnosis:
Clinical criteria:
Radiological criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiheng Chen, MD Dr. | Contact | +861084739047 | weihchenwj@126.com | |
| Jiuyi Chen, MD Dr. | Contact | +868515609789 | jiuyichen@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiheng Chen, MD Dr. | ICMJE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine | Recruiting | Beijing | Beijing Municipality | 100102 | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Kangguzengsheng capsule | Drug | Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day |
|
|
| D012216 |
| Rheumatic Diseases |