NCT05508815

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

February 9, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

August 15, 2022

Last Update Submit

May 24, 2023

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (5)

  • Fatigue scale-14

    12 weeks

  • Visual analogue scale pain scores

    12 weeks

  • Traditional chinese medicine symptom scores

    12 weeks

  • Erythrocyte sedimentation rate

    12 weeks

  • C-reactive protein

    12 weeks

Study Arms (2)

Modified Zhiwang Decoction Combined with Methotrexate

EXPERIMENTAL
Drug: Modified Zhiwang Decoction Combined with methotrexate

Methotrexate

ACTIVE COMPARATOR
Drug: Methotrexate

Interventions

Modified Zhiwang Decoction Combined with methotrexateDRUG

Modified Zhiwang Decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks.

Modified Zhiwang Decoction Combined with Methotrexate
MethotrexateDRUG

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

Methotrexate

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Related Publications (1)

  • Zhang N, Zhang LB, Wang Z, Lan TY, Wang JP, Xiao C, Tao QW, Xu Y. Efficacy and safety of the modified Zhiwang decoction combined with methotrexate in early rheumatoid arthritis: study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 18;14(1):e076571. doi: 10.1136/bmjopen-2023-076571.

    PMID: 38238175DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yuan Xu

    China-Japan Friendship Hospital

    STUDY CHAIR

  • Cheng Xiao

    China-Japan Friendship Hospital

    STUDY DIRECTOR

Central Study Contacts

Liu-bo Zhang

CONTACT

86-10-84205067597810955@qq.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 15, 2022

First Posted

August 19, 2022

Study Start

February 9, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 25, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)