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

Arthritis, Rheumatoid Clinical Trial

Official title:

The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05508815
• Other study ID #: zliubo
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 9, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Beijing University of Chinese Medicine
• Contact: Liu-bo Zhang
• Phone: 86-10-84205067
• Email: 597810955[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Modified Zhiwang Decoction Combined with methotrexate
Modified Zhiwang Decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks.
• Methotrexate
Methotrexate(7.5-15mg, once a week) for 12 weeks.

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DAS28 based on erythrocyte sedimentation rate scores	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.	12 weeks
Secondary	Fatigue scale-14	The fatigue scale-14 is a standardized questionnaire regarding physical and mental fatigue. The higher the score, the greater the fatigue.	12 weeks
Secondary	Visual analogue scale pain scores	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.	12 weeks
Secondary	Traditional chinese medicine symptom scores	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%	12 weeks
Secondary	Erythrocyte sedimentation rate		12 weeks
Secondary	C-reactive protein		12 weeks