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

Primary Purpose

Arthritis, Rheumatoid

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Modified Zhiwang Decoction Combined with methotrexate
Methotrexate
Sponsored by
Beijing University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Zhiwang Decoction Combined with Methotrexate

Methotrexate

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fatigue scale-14
The fatigue scale-14 is a standardized questionnaire regarding physical and mental fatigue. The higher the score, the greater the fatigue.
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.
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%
Erythrocyte sedimentation rate
C-reactive protein

Full Information

First Posted
August 15, 2022
Last Updated
May 24, 2023
Sponsor
Beijing University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05508815
Brief Title
Modified Zhiwang Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis
Official Title
The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Zhiwang Decoction Combined with Methotrexate
Arm Type
Experimental
Arm Title
Methotrexate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Modified Zhiwang Decoction Combined with methotrexate
Intervention Description
Modified Zhiwang Decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate(7.5-15mg, once a week) for 12 weeks.
Primary Outcome Measure Information:
Title
DAS28 based on erythrocyte sedimentation rate scores
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fatigue scale-14
Description
The fatigue scale-14 is a standardized questionnaire regarding physical and mental fatigue. The higher the score, the greater the fatigue.
Time Frame
12 weeks
Title
Visual analogue scale pain scores
Description
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.
Time Frame
12 weeks
Title
Traditional chinese medicine symptom scores
Description
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%
Time Frame
12 weeks
Title
Erythrocyte sedimentation rate
Time Frame
12 weeks
Title
C-reactive protein
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu-bo Zhang
Phone
86-10-84205067
Email
597810955@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Xu
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cheng Xiao
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu-bo Zhang
Phone
+861084205067
Email
597810955@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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