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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-09

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified Zhiwang Decoction Combined with Methotrexate

Group Type EXPERIMENTAL

Modified Zhiwang Decoction Combined with methotrexate

Intervention Type DRUG

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

Methotrexate

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Methotrexate

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No