A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
April 7, 2015 updated by: University of Minnesota
The purpose of this study is to evaluate the efficacy and safety of a combined therapy for rheumatoid arthritis (RA).
The combined therapy contained paeoniflorin (Brand name: Pafulin), which has anti-inflammation properties, and Cervus and Cucumis polypeptide injection (Brand name: Songmeile), which has bone healing, pain relieving, and anti-inflammation properties.
The hypothesis is that this remedy, which has long been used by the world's largest RA community, is effective and safe when tested by modern clinical standards and criteria.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a double-blinded randomized study on the treatment of rheumatoid arthritis.
In particular, patients were randomly assigned to one of the following treatment groups: Paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), Methotrexate (MTX) + Leflunomide (LEF), and MTX + LEF + CCPI.
The therapeutic effectiveness was evaluated by the 7 core set measures of American College of Rheumatology (ACR).
Adverse effects, their severity, and the evaluators' professional judgments of relationships between the adverse effects and the drugs were documented.
Study Type
Interventional
Enrollment (Actual)
1748
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100050
- Beijing Friendship Hospital, Affiliated to Capital Medical University
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Taipa, China
- Institute of Chinese Medical Sciences, University of Macau
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age of 18 years or older
- active RA, defined by at least 8 swollen joints and at least 10 tender joints (excluding distal interphalangeal joints)
- an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour
- the 1987 revised American College of Rheumatology (ACR) criteria for diagnosis of RA for at least 6 months
- not use of NSAIDs within two weeks
- agreement to participate in this study.
Exclusion Criteria:
- poor compliance
- severe medical conditions
- abnormalities in liver, or kidney function, or in haematological parameters,
- pregnancy or breast feeding
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Paeoniflorin + Polypeptides (PAE + CCPI)
Paeoniflorin (PAE), the extract from peony (Paeonia lactiflora), is an active ingredient with anti-inflammation properties.
Polypeptides (3,000 - 10,000 dalton) in Cervus & Cucumis polypeptide injection (CCPI), the extract from Sika deer (Cervus nippon Temmick) bones and muskmelon (Cucumis melo L) seeds, are the active ingredients with bone healing, pain relieving, and anti-inflammation properties.
PAE was administrated orally 600 mg twice a day for at least 12 months.
CCPI was administered intravenously 8~12 mL daily with 250 mL 5% dextrose injection solution or 0.9% NaCl IV solution for 2 weeks, discontinued 1 week, and restarted for another 2 weeks.
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The comparisons of the efficacy and safety of the following treatments for rheumatoid arthritis: paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), methotrexate (MTX) + leflunomide (LEF), and MTX + LEF + CCPI.
Other Names:
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ACTIVE_COMPARATOR: Methotrexate (MTX) + Leflunomide (LEF)
DMARDs (methotrexate: MTX, leflunomide: LEF) were taken orally for at least 12 months.
MTX dose: 7.5 mg ~ 10mg / week, LEF dose: 10 mg ~ 20mg daily.
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The comparisons of the efficacy and safety of the following treatments for rheumatoid arthritis: paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), methotrexate (MTX) + leflunomide (LEF), and MTX + LEF + CCPI.
Other Names:
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ACTIVE_COMPARATOR: MTX + LEF + CCPI
The DMARDs and CCPI were administrated as in the above two groups.
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The comparisons of the efficacy and safety of the following treatments for rheumatoid arthritis: paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), methotrexate (MTX) + leflunomide (LEF), and MTX + LEF + CCPI.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures.
Time Frame: CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
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The American College of Rheumatology (ACR) core set measure improvement % response rate was used to assess the relief of rheumatoid arthritis symptoms and the improvement of functions.
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CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The adverse effects associated with the treatments
Time Frame: CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
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The following parameters were used to measure the safety of the treatments: Headache, Up resp infection, Urinary tract infection, Other infection, Nausea, Rash, Diarrhea, Fatigue, Alopecia, Rhinitis, Dizziness, Abdominal pain, Sinusitis, Mouth ulcer, Hypertension, Dyspepsia, Vomiting, Insomnia, ALT elevation, AST elevation, WBC decrease, Glucose elevation, etc.
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CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2004
Primary Completion (ACTUAL)
April 1, 2011
Study Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
April 5, 2012
First Submitted That Met QC Criteria
May 15, 2012
First Posted (ESTIMATE)
May 17, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1205E14290
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