Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Lingzhi and Sen Miao San

• Registration Number: NCT00432484
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2007-02-06
• Study First Submitted QC: 2007-02-06
• Study First Posted: 2007-02-07
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-06
• Last Update Posted: 2008-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lingzhi and Sen Miao San	Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San

Primary Outcome Measures

Name	Time	Method
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).	wk52

Secondary Outcome Measures

Name	Time	Method
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.	wk52

Trial Locations

Locations (1)

The Institute of Chinese Medicine; 🇨🇳 Hong Kong, China