The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- DAS28 based on erythrocyte sedimentation rate scores
Study Overview
Brief Summary
The aim of this study is to evaluate the effectiveness and safety of Modified Zhiwang Decoction in combination with methotrexate for the treatment of early RA patients and a parallel-group, single-center randomized controlled clinical study was designed.
Detailed Description
Rheumatoid Arthritis(RA) is a progressive inflammatory autoimmune disease characterized by chronic systemic inflammation, which can cause swelling, stiffening and articular cartilage and bone destruction. Early diagnosis and treatment in RA can improve outcomes and slow progression of joint damage. Modified Zhiwang Decoction(MZWD) has great curative effects for treating RA. However, few randomized clinical trials(RCTs) have evaluated the effectiveness of MZWD for the treatment of early RA. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of MZWD combined with methotrexate on early RA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 16-70 years old;
- •Patients who meet the diagnostic criteria of 2010 ACR/EULAR .
- •Patients who meet the diagnostic criteria of cold pattern.
- •Disease activity score(DAS28) ≤5.2.
Exclusion Criteria
- •Patients accompanied with other rheumatic diseases or severe pain due to other medical conditions, such as diabetic pain or post-herpetic neuralgia;
- •Patients with joint dysfunction and the X-ray score of wrists is grade IV;
- •Patients accompanied with mental and psychological disorders such as cognitive impairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervous system diseases.
- •Patients accompanied with organ injury or malignant tumors, disorders of the cardiovascular system, liver(ALT/AST>3 times higher than the upper limit of normal), kidneys(Ccr<60ml/min), brain, or hematopoietic system.
- •Pregnant and lactating women.
- •Patients are participation in any other clinical trials.
- •Patients who are allergic to the drugs used in this study.
Arms & Interventions
Modified Zhiwang Decoction Combined with Methotrexate
Intervention: Modified Zhiwang Decoction Combined with methotrexate (Drug)
Methotrexate
Intervention: Methotrexate (Drug)
Outcomes
Primary Outcomes
DAS28 based on erythrocyte sedimentation rate scores
Time Frame: 12 weeks
DAS28 is widely accepted to evaluate RA disease activity and consists of number of tender joints out of 28, number of swollen joints out of 28, ESR and the patient's global assessment of disease activity.
Secondary Outcomes
- Fatigue scale-14(12 weeks)
- Visual analogue scale pain scores(12 weeks)
- Traditional chinese medicine symptom scores(12 weeks)
- Erythrocyte sedimentation rate(12 weeks)
- C-reactive protein(12 weeks)
Investigators
zhang liubo
MD
Beijing University of Chinese Medicine