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Completed

NCT Number: NCT00432484

Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Institute of Chinese Medicine

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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).

    Time frame: wk52

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.

    Time frame: wk52

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 7, 2007
Registry last updated
May 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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