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Clinical observation of Buzhong Guizhi Zhibi Decoction on rheumatoid arthritis syndrome of Qi and blood deficiency

Clinical observation of Buzhong Guizhi Zhibi Decoction on rheumatoid arthritis syndrome of Qi and blood deficiency - Clinical observation on Buzhong Guizhi Zhibi Decoction treating Qi and blood deficiency syndrome of RA

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070837
Enrollment
Unknown
Registered
2023-04-24
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Control group:MTX,Folic acid tablet
Treatment group:Buzhong Guizhi Zhibi Decoction, MTX, Folic acid tablet

Sponsors

Yunnan Hospital of Traditional Chinese Medicine / The No.1 Affiliated Hospital of Yunnan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Consistent with Western diagnostic standards for rheumatoid arthritis; 2. RA patients who meet the criteria for TCM syndrome of Qi and blood deficiency; 3. Rheumatoid arthritis disease activity criteria were met (DAS28<=3.2); 4. Aged between 18 and 75 years old (regardless of gender, including 18 and 75 years old); 5. The patient knows and voluntarily participates in the clinical study, agrees to sign the informed consent to enter the clinical study, and can actively cooperate with the doctor for treatment,observation and follow-up. Note: According to the above criteria, patients can be excluded if they cannot meet 1 of the criteria.

Exclusion criteria

Exclusion criteria: 1. History of severe respiratory, blood circulation, digestive tract, endocrine, urinary system diseases and malignant tumors before participating in the experiment; 2. Participants are participating in other drug clinical trials,or the drug clinical trial group is less than 1 week; 3. Patients who fail to complete drug treatment as prescribed by the doctor, cannot judge the efficacy, have poor compliance, or have incomplete data; 4. Allergic to experimental drugs; 5. During screening,abnormalities were found in relevant laboratory indicators,such as Cr exceeding 1.5 times the upper limit of normal value, ALT or AST>=2 times the upper limit of normal value; 6. Pregnant, lactating or expectant women; 7. History of neuropsychiatric disorders (epilepsy, depression, etc.); 8. Suspected or existing history of alcohol or drug abuse,or other medical conditions that reduce or compli- cate enrollment, such as frequent changes in the work environment, may cause loss of follow-up. Note: Patients with any one of the above criteria can be excluded.

Design outcomes

Primary

MeasureTime frame
erythrocyte;hemoglobin;Classification of rheumatoid factors;CCP;ESR;CRP;Number of joint tenderness;Number of joint swelling;DAS28 score;TCM syndrome score;Evaluation of patient pain (rest pain);Doctor's evaluation of patient's joint pain;electrocardiogram;Chest CT;

Secondary

MeasureTime frame
Liver function;renal function;Urine routine;Fecal routine and occult blood;

Countries

China

Contacts

Public ContactChen YanLin

Yunnan Hospital of Traditional Chinese Medicine / The No.1 Affiliated Hospital of Yunnan University of Chinese Medicine

ynkmpzj@126.com+86 138 8834 0962

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026