NCT05508815

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

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Beijing University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
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.
DRUG	Methotrexate	Methotrexate(7.5-15mg, once a week) for 12 weeks.

Timeline

• Start date: 2023-02-09
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-08-19
• Last updated: 2023-05-25

Locations

1 site across 1 country: China