Knee Osteoarthritis
Conditions
Keywords
Guli capsule, knee osteoarthritis, Changing of WOMAC and VAS score
Brief summary
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.
Detailed description
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.
Interventions
DRUGGuli capsule
Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day
DRUGKangguzengsheng capsule
Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day
Sponsors
Guizhou Bailing Group Pharmaceutical Co Ltd
Wangjing Hospital, China Academy of Chinese Medical Sciences
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
People's Hospital of Anshun City of Guizhou Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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: 1. most of the time have knee pain nearly a month 2. bone fricative 3. morning stiffness is less than or equal to 30 min 4. age is more than or equal to 38 years 5. bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis. * Radiological criteria: 1. most of the time have knee pain nearly a month 2. the X-ray showed osteophyte formation 3. joint fluid examination confirmed with osteoarthritis 4. age is more than or equal to 40 years 5. morning stiffness is less than or equal to 30 min 6. bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6).
Exclusion criteria
* Patient with a history of allergy to similar constituents or chemical components of the drug; * Patients with limited liver and kidney function; * Patients with hematopoietic system disease; * Patients with diabetes, Cushing's syndrome and other endocrine disorders; * Patients with severe heart and brain disease; * Patients with low immunity; * Patients directly involved with the staff in the study; * Women during pregnancy or lactation; * Participating in other clinical studies or Participated in 3 months; * The investigators judged who be unfit for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pain Scores on the Visual Analog Scale | 4 weeks |
| Number of Participants with Adverse Events as a Measure of Safety | 4 weeks |
Countries
China
Contacts
Primary ContactWeiheng Chen, MD Dr.
Backup ContactJiuyi Chen, MD Dr.
Outcome results
None listed