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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600521
• Other study ID #: 1205E14290
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: April 7, 2015
• Start date: November 2004
• Est. completion date: March 2012

Study information

• Verified date: April 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1748
• Est. completion date: March 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Affiliated to Capital Medical University	Beijing
China	Institute of Chinese Medical Sciences, University of Macau	Taipa

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures.	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.	CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.	No
Secondary	The adverse effects associated with the treatments	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.	CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.	No

External Links

•   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)
•   Homepage of Beijing Friendship Hospital, which is one of the largest hospitals in China with 1256 beds and an average of roughly 7000 daily outpatient visits.