osteoarthritis
Conditions
Interventions
Group 1:alamod combined with glucosamine sulfate
Group 2:glucosamine sulfate
Sponsors
Department of Rheumatology and Immunology, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to specific procedures related to the study, subjects should be able to read and provide written signatures and dated informed consent and be able to participate in the study in accordance with GCP and applicable regulations. 2. Understand, be able and willing to fully comply with research procedures and restrictions. 3. Male or female patients aged from 40 (inclusive) to 75 (inclusive). 4. Women participating in the study should be infertile (defined as at least 1 year after menopause, or have undergone sterilization [bilateral tubal ligation, bilateral ovariectomy, or total hysterectomy]), or are willing to use at least one of the following medically acceptable contraceptive methods: (1) Before using the trial medication, use hormonal contraceptive methods, such as oral, implant, injection, vaginal ring, or percutaneous contraceptive use, for at least 1 complete cycle (depending on the subject's usual menstrual cycle). (2) Intrauterine device. (3) Double barrier method (condom, sponge, or diaphragm with spermicidal gel / cream). 5. In accordance with the standards of the American Rheumatic Society, primary knee osteoarthritis(OA) must be diagnosed by clinical and / or imaging examination, meets at least 4 of the following 6 criteria: (1) Aged >= 50 years. (2) After getting up in the morning, the stiffness lasts less than 30 minutes. (3) Twist pronunciation (joint). (4) Bone tenderness. (5) Bony enlargement. (6) Non-articular fever. 6. The history of clinical symptoms of knee joint OA should be more than 3 months. 7. Throughout the study treatment, subjects were required to avoid non-habitual physical activity (such as starting a new weightlifting exercise). 8. In addition to joint OA, the subjects must be in good health, including according to the judgment of the researchers, the subjects' medical history, vital signs, physical examination, electrocardiogram and routine laboratory tests are not likely to interfere with the safety indicators or clinically significant abnormalities in the evaluation of pain and function.
Exclusion criteria
Exclusion criteria: 1. The subjects had a history of trauma, which affected the knee joint. 2. Have a history of knee arthroplasty, arthroplasty or other knee joint surgery. 3. The researchers determined that the subjects had significant injuries involving the target knee joint within 6 months before screening. 4. The subjects were treated with opioids or glucocorticoids within 30 days before screening, or who needed to use opioids or glucocorticoids for long-term treatment during the study. 5. Within 3 months before screening, the subjects were treated with intra-knee injection of steroids, hyaluronic acid, or tonics. 6. Except for aspirin not more than 325 mg/ days for the prevention of heart disease, the subjects used anticoagulants within one month before screening. 7. During the screening visit, or the baseline visit (day 1), the subjects' stool occult blood test was positive. 8. Subjects have a history of chronic pain (e.g. rheumatoid arthritis, psoriatic arthritis, gouty arthritis, fibromyalgia) or other conditions that may affect the target joint, or its function and pain assessment (e.g. osteonecrosis, cartilage calcification). 9. According to the researchers, subjects suffering from any clinically unstable heart, respiratory, neurological, immune, blood, or kidney disease, or any other conditions that may harm the interests of the subjects, or impair communication with researchers, should be prohibited from participating in the trial. 10. The subjects have obvious liver and kidney diseases and laboratory abnormalities, which were defined as: a) glutamic oxaloacetic transaminase, glutamic pyruvic transaminase and lactate dehydrogenase >= 3 x upper limit of normal value [ULN]; or b) creatinine or total bilirubin >= 1.5 x ULN; or c) hemoglobin 170mmHg or diastolic blood pressure > 90 mmHg (which can be re-measured after a 5-minute rest). 14. Female subjects who are pregnant, planning to become pregnant or breastfeeding. 15. Subjects who are known to be addicted to alcohol or other drugs. 16. Subjects have participated in any other clinical trials in the past 3 months, or during the five metabolic half-lives of other clinical trial drugs. 17. The researchers believe that the subjects have any situation that endangers the evaluation of efficacy or the safety of the subjects, or poor compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| scale of WOMAC; | — |
Countries
China
Contacts
Public ContactLingli Dong
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology?
Outcome results
None listed