Clinical trial NCT01600521: A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
Official title: A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 1748
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures.
timeFrame: CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
Secondary outcomes:
measure: The adverse effects associated with the treatments
timeFrame: CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Affiliated to Capital Medical University
city: Taipa
country: China
facility: Institute of Chinese Medical Sciences, University of Macau
Study officials:
References:
citation: 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.