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

NCT ID: NCT01600521

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1748 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2012-03-31

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs

Intervention Type: DRUG

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.

MTX + LEF + CCPI

The DMARDs and CCPI were administrated as in the above two groups.

Group Type: ACTIVE_COMPARATOR

A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention 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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Friendship Hospital, Affiliated to Capital Medical University

Beijing, , China

Institute of Chinese Medical Sciences, University of Macau

Taipa, , China

Countries

China

References

Chen L, Qi H, Jiang D, Wang R, Chen A, Yan Z, Xiao J. The new use of an ancient remedy: a double-blinded randomized study on the treatment of rheumatoid arthritis. Am J Chin Med. 2013;41(2):263-80. doi: 10.1142/S0192415X13500195.

Reference Type: DERIVED

PMID: 23548118 (View on PubMed)

Related Links

http://www.prb.org/pdf11/2011population-data-sheet_eng.pdf

China has the world's largest RA patient population. Its population is more than four times the population of the United States (1,346vs.312 millions), and almost two times the total populations of all European countries combined (1,346vs.740 millions)

Other Identifiers

1205E14290

Identifier Type: -

Identifier Source: org_study_id