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

May 24, 2023 updated by: zhang liubo, Beijing University of Chinese Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methotrexate
Drug: Methotrexate
Methotrexate(7.5-15mg, once a week) for 12 weeks.
Experimental: Modified Zhiwang Decoction Combined with Methotrexate
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAS28 based on erythrocyte sedimentation rate scores
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: 12 weeks
12 weeks
Fatigue scale-14
Time Frame: 12 weeks
The fatigue scale-14 is a standardized questionnaire regarding physical and mental fatigue. The higher the score, the greater the fatigue.
12 weeks
Visual analogue scale pain scores
Time Frame: 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.
12 weeks
Traditional chinese medicine symptom scores
Time Frame: 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%
12 weeks
Erythrocyte sedimentation rate
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing University of Chinese Medicine

Investigators

  • Study Chair: Yuan Xu, China-Japan Friendship Hospital
  • Study Director: Cheng Xiao, China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 15, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zliubo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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