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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
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Lingzhi and Sen Miao San
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

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). [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: wk52 ] [ Designated as safety issue: Yes ]

Enrollment: 70
Study Start Date: May 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432484

Locations
China
The Institute of Chinese Medicine
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Edmund K Li, MD Chinese University of Hong Kong
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lai-Shan Tam, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00432484     History of Changes
Other Study ID Numbers: RA-2005-001
Study First Received: February 6, 2007
Last Updated: May 6, 2008
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Lingzhi
Sen Miao San
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013