Clinical trial NCT05508815: Modified Zhiwang Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis
Official title: The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Arthritis, Rheumatoid
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: DAS28 based on erythrocyte sedimentation rate scores
timeFrame: 12 weeks
Secondary outcomes:
measure: Fatigue scale-14
timeFrame: 12 weeks
measure: Visual analogue scale pain scores
timeFrame: 12 weeks
measure: Traditional chinese medicine symptom scores
timeFrame: 12 weeks
measure: Erythrocyte sedimentation rate
timeFrame: 12 weeks
measure: C-reactive protein
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
affiliation: China-Japan Friendship Hospital
name: Yuan Xu
role: STUDY_CHAIR
affiliation: China-Japan Friendship Hospital
name: Cheng Xiao
role: STUDY_DIRECTOR
References: