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

Last updated: May 24, 2023
Sponsor: Beijing University of Chinese Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

Rheumatoid Arthritis

Joint Injuries

Treatment

Methotrexate

Modified Zhiwang Decoction Combined with methotrexate

Clinical Study ID

NCT05508815
zliubo
  • Ages 16-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients accompanied with other rheumatic diseases or severe pain due to other medicalconditions, 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 cognitiveimpairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebralhemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervoussystem diseases.
  • Patients accompanied with organ injury or malignant tumors, disorders of thecardiovascular 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.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Methotrexate
Phase: 1
Study Start date:
February 09, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • China-Japan Friendship Hospital

    Beijing,
    China

    Active - Recruiting

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