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Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00432484
First received: February 6, 2007
Last updated: May 6, 2008
Last verified: May 2008
History of Changes

February 6, 2007
May 6, 2008
May 2005
December 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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).
Complete list of historical versions of study NCT00432484 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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.
Not Provided
Not Provided
 
Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study

To study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Lingzhi and Sen Miao San
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.
Other Names:
  • Pingyin English name
  • Lingzhi Ganoderma lucidum seu Japonicum
  • Cangzhu Atractylodes lancea
  • Huangbo Phellodendron amurense
  • Niuxi Achyranthes bidentata B1
Placebo Comparator: 1
Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San
Intervention: Drug: Lingzhi and Sen Miao San
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00432484
RA-2005-001
No
Lai-Shan Tam, The Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
Chinese University of Hong Kong
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP