Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Lingzhi and Sen Miao San
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Lingzhi, Sen Miao San, Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA.
- The presence of 2 or more swollen or tender joints, based on 28-joint count.
- Morning stiffness lasting for 30 minutes.
- Erythrocyte sedimentation rate (ESR) of 28 mm/hour, despite treatment with disease modifying agent including MTX, sulphasalazine, hydroxychloroquine, auranofin or azathioprine were recruited into the study.
- Patients taking glucocorticoids (prednisone < 7.5 mg/day) and/or nonsteroidal antiinflammatory drugs must have been taking a stable dosage for at least 4 weeks before entering the trial and were required to take the same dosage throughout the trial.
- Patients had radiographic erosive diseases.
Exclusion Criteria:
- Patients who are pregnant or nursing mothers.
- Severe liver disease (e.g cirrhosis, chronic active hepatitis)
- Renal impairment (serum creatinine level > 150mmol/L)
- Known hypersensitivity to herbal medicine
Sites / Locations
- The Institute of Chinese Medicine
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
1
Arm Description
Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San
Outcomes
Primary Outcome Measures
We assessed the proportion of patients showing a clinical response of at least 20% and 50% as defined by the American College of Rheumatology (ACR) criteria (20).
Secondary Outcome Measures
The change in the number of swollen and tender joint counts, and the levels of ESR, CRP, the inflammatory markers, cytokine levels and oxidative stress will be assessed as secondary outcomes.
Full Information
NCT ID
NCT00432484
First Posted
February 6, 2007
Last Updated
May 6, 2008
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00432484
Brief Title
Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
Official Title
Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA.
Detailed Description
It is a prospective, double-blind, randomized, placebo-controlled study in patients with RA. It consists of a 24 - weeks period of randomized double-blind treatment of either TCM(Lingzhi and Sen Miao San)or placebo.
Primary outcome is assessed by showing a clinical response of at least 20% and 50% as defined by the American College of Rheumatology (ACR) criteria.Secondary outcome is defined as the changes in the number of swollen and tender joint counts, and the levels of ESR, CRP, the inflammatory markers, cytokine levels and oxidative stress.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Lingzhi, Sen Miao San, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San
Intervention Type
Drug
Intervention Name(s)
Lingzhi and Sen Miao San
Other Intervention Name(s)
Pingyin English name, Lingzhi Ganoderma lucidum seu Japonicum, Cangzhu Atractylodes lancea, Huangbo Phellodendron amurense, Niuxi Achyranthes bidentata B1
Intervention Description
G lucidum and SMS were supplied as capsules, containing 4.0 gm of G lucidum extract, 2.4 gm of Rhizoma atractylodis (Cangzhu), 2.4 gm of Cotex phellodendri(Huangbai), and 2.4 gm of Radix achyranthes Bidentatae(Niuxi). Each patient took either 3 capsules twice daily as recommended by the TCM experts or identical-looking placebo.
Primary Outcome Measure Information:
Title
We assessed the proportion of patients showing a clinical response of at least 20% and 50% as defined by the American College of Rheumatology (ACR) criteria (20).
Time Frame
wk52
Secondary Outcome Measure Information:
Title
The change in the number of swollen and tender joint counts, and the levels of ESR, CRP, the inflammatory markers, cytokine levels and oxidative stress will be assessed as secondary outcomes.
Time Frame
wk52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA.
The presence of 2 or more swollen or tender joints, based on 28-joint count.
Morning stiffness lasting for 30 minutes.
Erythrocyte sedimentation rate (ESR) of 28 mm/hour, despite treatment with disease modifying agent including MTX, sulphasalazine, hydroxychloroquine, auranofin or azathioprine were recruited into the study.
Patients taking glucocorticoids (prednisone < 7.5 mg/day) and/or nonsteroidal antiinflammatory drugs must have been taking a stable dosage for at least 4 weeks before entering the trial and were required to take the same dosage throughout the trial.
Patients had radiographic erosive diseases.
Exclusion Criteria:
Patients who are pregnant or nursing mothers.
Severe liver disease (e.g cirrhosis, chronic active hepatitis)
Renal impairment (serum creatinine level > 150mmol/L)
Known hypersensitivity to herbal medicine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund K Li, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Institute of Chinese Medicine
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
17907228
Citation
Li EK, Tam LS, Wong CK, Li WC, Lam CW, Wachtel-Galor S, Benzie IF, Bao YX, Leung PC, Tomlinson B. Safety and efficacy of Ganoderma lucidum (lingzhi) and San Miao San supplementation in patients with rheumatoid arthritis: a double-blind, randomized, placebo-controlled pilot trial. Arthritis Rheum. 2007 Oct 15;57(7):1143-50. doi: 10.1002/art.22994.
Results Reference
derived
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Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
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