Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis

May 6, 2008 updated by: Chinese University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • The Institute of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
wk52

Secondary Outcome Measures

Outcome Measure
Time Frame
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
wk52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Edmund K Li, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (Estimate)

February 7, 2007

Study Record Updates

Last Update Posted (Estimate)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-2005-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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