Modified Zhiwang Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis

Early Phase 1

Recruiting

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Modified Zhiwang Decoction Combined with methotrexate; Drug: Methotrexate

• Registration Number: NCT05508815
• Lead Sponsor: Beijing University of Chinese Medicine

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 Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-17
• Study First Posted: 2022-08-19
• Study Start: 2023-02-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Zhiwang Decoction Combined with Methotrexate	Modified Zhiwang Decoction Combined with methotrexate	-
Methotrexate	Methotrexate	-

Primary Outcome Measures

Name	Time	Method
DAS28 based on erythrocyte sedimentation rate scores	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 Outcome Measures

Name	Time	Method
Fatigue scale-14	12 weeks	The fatigue scale-14 is a standardized questionnaire regarding physical and mental fatigue. The higher the score, the greater the fatigue.
Visual analogue scale pain scores	12 weeks	Visual analogue scale pain score is utilized to quantify the pain level that ranges from 0 to 10. A VAS score of 0 means no pain and a score of 10 means unbear-able pain.
Traditional chinese medicine symptom scores	12 weeks	Traditional chinese medicine symptom score is calculated based on the percentage of symptom score reduction(PSSR) and the formula is as follows: PSSR=((symptom score before treatment-symptom score after treatemt)/(symptom score before treatment))×100%
Erythrocyte sedimentation rate	12 weeks
C-reactive protein	12 weeks

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China