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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Affiliated to Capital Medical University, Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs

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.

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 outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2004
Primary completion: 2011
Study completion: 2012
First posted: May 17, 2012
Registry last updated: Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed