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A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications

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ClinicalTrials.gov Identifier: NCT01600521
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
Study Start Date : November 2004
Actual Primary Completion Date : April 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs
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:
  • TGP: Lansen Pharmaceuticals, China. Brand name: Pafulin.
  • CCPI: Gloria Pharmaceuticals, China. Brand name: Songmeile.
  • MTX: Shanghai Sine Pharmaceuticalx, China.
  • LEF: Changzheng-Xinkai Sino-American Pharmaceutical, China

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.
Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs
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:
  • TGP: Lansen Pharmaceuticals, China. Brand name: Pafulin.
  • CCPI: Gloria Pharmaceuticals, China. Brand name: Songmeile.
  • MTX: Shanghai Sine Pharmaceuticalx, China.
  • LEF: Changzheng-Xinkai Sino-American Pharmaceutical, China

Active Comparator: MTX + LEF + CCPI
The DMARDs and CCPI were administrated as in the above two groups.
Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs
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:
  • TGP: Lansen Pharmaceuticals, China. Brand name: Pafulin.
  • CCPI: Gloria Pharmaceuticals, China. Brand name: Songmeile.
  • MTX: Shanghai Sine Pharmaceuticalx, China.
  • LEF: Changzheng-Xinkai Sino-American Pharmaceutical, China




Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600521


Locations
China
Beijing Friendship Hospital, Affiliated to Capital Medical University
Beijing, China, 100050
Institute of Chinese Medical Sciences, University of Macau
Taipa, China
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01600521     History of Changes
Other Study ID Numbers: 1205E14290
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Leflunomide
Peoniflorin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents