Arthritis (rheumatoid arthritis, knee osteoarthritis)
Conditions
Interventions
Experimental group:After 12 weeks of oral
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Rheumatoid arthritis 1. Meet the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) diagnostic criteria for rheumatoid arthritis (RA); 2. VAS score for arthralgia = 3 at inclusion 3. The subjects who plan to take Tongluo Kaibi tablets should be 18 years old at the time of signing the informed consent, and gender is not limited 4. If the subject is currently using DMARDs, he/she must have been treated at a stable dose for at least 1 month before enrollment; Subjects treated with leflunomide (LEF) or biologics must have been treated at a stable dose for at least 3 months prior to enrollment; Subjects who have not used hormones for 2 weeks or who have used hormones must have been on a stable dose for at least 2 weeks (dose = 10mg/ day). If subjects are on NSAIDs or other analgesics for RA, they must have been on a stable dose for at least 1 week prior to enrol 5. Sign the informed consent voluntarily and abide by the clinical study protocol to complete the study. Knee osteoarthritis 1. It meets the diagnostic criteria of knee osteoarthritis in the Guidelines for the Diagnosis and Treatment of osteoarthritis of the Chinese Society of Osteology in 2018 2. VAS score for arthralgia = 3 at inclusion 3. The subjects who plan to take Tongluo Kaibi tablets should be at least 18 years old when signing the informed consent, and gender is not limited 4. If subjects are using NSAIDs or other analgesics, they must have been treated at a stable dose for at least 1 week prior to enrollment 5. Sign the informed consent voluntarily and abide by the clinical study protocol to complete the study.
Exclusion criteria
Exclusion criteria: 1. Patients with serious primary diseases of cardiovascular and cerebrovascular system, liver and kidney, hematopoietic system, mental diseases, or other serious diseases affecting their survival are judged by the researchers to be not suitable for the study; 2. A history of trauma, ligament injury, fracture or surgery within 6 months resulting in pain or functional problems 3. Allergic to Tongluo Kaibi tablet or its components, or allergic constitution 4. Pregnant and breastfeeding women 5. Those who have planned to have a family in the past 6 months 6. Participating in another clinical investigator program 7. Other patients deemed unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue pain score;Health Assessment Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| The doctor assessed the general condition of the disease;ACR20;Patients self-assessed the overall status of the disease;WOMAC;DAS-28;Rheumatoid arthritis Chinese medicine symptom score;CDAI;Chinese medicine symptom score of knee osteoarthritis; | — |
Countries
China
Contacts
Public ContactQingman H uang
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed