Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

NCT00432484 | Completed Phase 2

• 1 other identifier: RA-2005-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Lingzhi; Sen Miao San; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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).

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Secondary Outcomes (1)

• 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.

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Study Arms (1)

1

PLACEBO COMPARATOR

Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San

Drug: Lingzhi and Sen Miao San

Interventions

Lingzhi and Sen Miao San DRUG

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.

Also known as: Pingyin English name, Lingzhi Ganoderma lucidum seu Japonicum, Cangzhu Atractylodes lancea, Huangbo Phellodendron amurense, Niuxi Achyranthes bidentata B1

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Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Institute of Chinese Medicine

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 17907228 DERIVED

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 Officials

• Edmund K Li, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2007
• First Posted: February 7, 2007
• Study Start: May 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

CN (1)