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

NCT01600521 | Completed DMC

• 1 other identifier: 1205E14290
• Study Type: interventional
• Target: 1,748
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• The adverse effects associated with the treatments

  CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.

Study Arms (3)

Paeoniflorin + Polypeptides (PAE + CCPI)

ACTIVE COMPARATOR

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.

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

Methotrexate (MTX) + Leflunomide (LEF)

ACTIVE COMPARATOR

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.

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

MTX + LEF + CCPI

ACTIVE COMPARATOR

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

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

Interventions

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.

Also known as: 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

MTX + LEF + CCPI; Methotrexate (MTX) + Leflunomide (LEF); Paeoniflorin + Polypeptides (PAE + CCPI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• poor compliance
• severe medical conditions
• abnormalities in liver, or kidney function, or in haematological parameters,
• pregnancy or breast feeding

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

Beijing Friendship Hospital, Affiliated to Capital Medical University

Beijing, 100050, China

Location

Institute of Chinese Medical Sciences, University of Macau

Taipa, China

Location

Related Publications (1)

• 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.

  PMID: 23548118 DERIVED

Related 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)

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: May 17, 2012
• Study Start: November 1, 2004
• Primary Completion: April 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CN (2)