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

University of Minnesota (UMN)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs

Study type: Interventional

Funder types: Other

Identifiers

NCT01600521

1205E14290

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,748 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,748 participants in 3 patient groups

Paeoniflorin + Polypeptides (PAE + CCPI)

Active Comparator group

Description:

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.

Treatment:

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

Methotrexate (MTX) + Leflunomide (LEF)

Active Comparator group

Description:

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.

Treatment:

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

MTX + LEF + CCPI

Active Comparator group

Description:

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

Treatment:

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