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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs

• Registration Number: NCT01600521
• Lead Sponsor: University of Minnesota

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2011-04
• Study Completion: 2012-03
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-17
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1748

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.

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Exclusion Criteria

• poor compliance
• severe medical conditions
• abnormalities in liver, or kidney function, or in haematological parameters,
• pregnancy or breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTX + LEF + CCPI	A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs	The DMARDs and CCPI were administrated as in the above two groups.
Paeoniflorin + Polypeptides (PAE + CCPI)	A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs	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.
Methotrexate (MTX) + Leflunomide (LEF)	A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs	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.

Primary Outcome Measures

Name	Time	Method
The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures.	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

Name	Time	Method
The adverse effects associated with the treatments	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.

Trial Locations

Locations (2)

Beijing Friendship Hospital, Affiliated to Capital Medical University; 🇨🇳 Beijing, China

Institute of Chinese Medical Sciences, University of Macau; 🇨🇳 Taipa, China