Back to resultsA Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
- Beijing Friendship Hospital, Affiliated to Capital Medical University
- Institute of Chinese Medical Sciences, University of Macau
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Paeoniflorin + Polypeptides (PAE + CCPI)
Methotrexate (MTX) + Leflunomide (LEF)
MTX + LEF + CCPI
Arm 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.
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.
The DMARDs and CCPI were administrated as in the above two groups.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01600521
Brief Title
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1748 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paeoniflorin + Polypeptides (PAE + CCPI)
Arm Type
Active Comparator
Arm 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.
Arm Title
Methotrexate (MTX) + Leflunomide (LEF)
Arm Type
Active Comparator
Arm 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.
Arm Title
MTX + LEF + CCPI
Arm Type
Active Comparator
Arm Description
The DMARDs and CCPI were administrated as in the above two groups.
Intervention Type
Drug
Intervention Name(s)
A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs
Other Intervention Name(s)
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
Intervention Description
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.
Primary Outcome Measure Information:
Title
The relief of rheumatoid arthritis symptoms and the improvement of functions assessed by the American College of Rheumatology (ACR) core set measures.
Description
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.
Time Frame
CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
Secondary Outcome Measure Information:
Title
The adverse effects associated with the treatments
Description
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.
Time Frame
CCPI: 2 weeks + 2 weeks with 1 week in between. All other drugs: at least 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Beijing Friendship Hospital, Affiliated to Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Institute of Chinese Medical Sciences, University of Macau
City
Taipa
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23548118
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.
Results Reference
derived
Links:
URL
http://www.bfh.com.cn/templates/T_second/index.aspx?nodeid=12
Description
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.
URL
http://www.prb.org/pdf11/2011population-data-sheet_eng.pdf
Description
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)
Learn more about this trial
A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications
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