rheumatoid arthritis(RA)
Conditions
Interventions
Traditional Tibetan Medicine Scheme Group:Traditional Tibetan Medicine Scheme Group Usage and Dosage 1 Chronological medication (1) in the morning: 2g of Jincainiao pills
(2) Noon: 2g of Pugajiua Pill
Or 2g of Twenty Three Flavor Tea Pills
(3) Evening: 1g of Puqiongjiua Pill
(4) Interval: Liechi'a Tang San 5g
2. Differentiation and flavor enhancement
Tibetan Medicine Optimization Plan Group:Tibetan Medicine Optimization Plan Group Usage and Dosage 1 Chronological medication (1) Morning: 2g of Se Zhu Tang Nai San
(3) Evening: 2g of Jincainiawan
Sponsors
Tibetan Hospital of Xizang Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 75 years old (including both ends), regardless of gender. 2. Those who meet the diagnostic criteria for rheumatoid arthritis in Western medicine during screening. 3. When screening, it meets the differentiation criteria for Tibetan medicine Changzhong cold syndrome. 4. During screening, it was diagnosed as moderate to low-grade active rheumatoid arthritis (2.6 = baseline DAS28-CRP score = 5.1). 5. Voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other rheumatic and immune diseases. 2. Patients with severe cardiovascular and cerebrovascular diseases, kidney disease, and liver disease. 3. Patients with severe infections, tumors, and infectious skin diseases. 4. Patients with late stage deformities, disabilities, or loss of labor in rheumatoid arthritis. 5. Patients with obvious skin lesions and ulcers in the affected area of the joint. 6. Individuals who are allergic to alcohol or experimental drugs. 7. Pregnant or lactating women, or those who are at risk of conception but have not taken effective contraceptive measures during the trial period. 8. Subjects with severe organic lesions, mental disorders, or other reasons who are unable to cooperate with treatment. 9. Those who have used biological agents in the past 3 months. 10. Those who have been participating in other clinical trials for the past month or are currently participating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who met ACR20 after 12 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Joint tenderness count (TJC) and joint swelling count (SJC) Evaluate the number of tenderness and swelling in 28 joints.;The changes and rates of erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), and C-reactive protein (CRP) compared to baseline after 4 and 12 weeks of treatment;;The changes and rate of joint tenderness count (TJC) and joint swelling count (SJC) from baseline after 4 and 12 weeks of treatment;;The change value and rate of disability index (HAQ-DI) from baseline in the health assessment questionnaire after 4 and 12 weeks of treatment;;Tibetan Medical Symptom Grading Scale;Changes in DAS28 scores from baseline after 4 and 12 weeks of treatment;;The change value and rate of pain VAS score from baseline after 4 and 12 weeks of treatment;;Pain evaluation Patients are required to evaluate their average pain over the past week on the Visual Analog Scale (VAS) (0-100mm), ranging from painless (0) to the most severe possible pain (100). This evaluation should be conducted before evaluating the number of tenderness and swelling joints. Visual Analog Scale (VAS);The changes in VAS scores of patients and clinical doctors compared to baseline after 4 and 12 weeks of treatment;;The proportion of subjects who met ACR20 after 4 weeks of treatment;; | — |
Countries
China
Contacts
Public ContactDawa
Tibetan Hospital of Xizang Autonomous Region
Outcome results
None listed