Guizhi Shaoyao Zhimu Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis

Beijing University of Chinese Medicine (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of Guizhi Shaoyao Zhimu decoction in combination with methotrexate for the treatment of early RA patients and a parallel-group, single-center randomized controlled clinical study was designed.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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. Guizhi Shaoyao Zhimu decoction(GSZD) has great curative effects for treating RA. However, few randomized clinical trials(RCTs) have evaluated the effectiveness of GSZD for the treatment of early RA. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of GSZD combined with methotrexate on early RA.

Study Design

Study Type:
Anticipated Enrollment :
150 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
The Efficacy and Safety of the Guizhi Shaoyao Zhimu Decoction Combined With Methotrexate in Early Rheumatoid Arthritis
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Guizhi Shaoyao Zhimu Decoction Combined with Methotrexate

Drug: Guizhi Shaoyao Zhimu decoction Combined with methotrexate
Guizhi Shaoyao Zhimu decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks.

Active Comparator: Methotrexate

Drug: Methotrexate
Methotrexate(7.5-15mg, once a week) for 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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%

  4. Erythrocyte sedimentation rate [12 weeks]

  5. C-reactive protein [12 weeks]

Eligibility Criteria


Ages Eligible for Study:
16 Years to 70 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 China-Japan Friendship Hospital Beijing China

Sponsors and Collaborators

  • Beijing University of Chinese Medicine


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

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
zhang liubo, MD, Beijing University of Chinese Medicine Identifier:
Other Study ID Numbers:
  • zliubo
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2022