Rheumatoid ArthritisPhase 2NCT00432484
Lingzhi and Sen Miao San for the Treatment of Rheumatoid Arthritis
A Phase 2 study testing Lingzhi and Sen Miao San in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To study the efficacy of TCM as an effective supplement in addition to the traditional treatment in RA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Lingzhi and Sen Miao San
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- May 2005to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Lingzhi and Sen Miao San
- Keywords
- Lingzhi, Sen Miao San, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingzhi and Sen Miao SanDrug
Also called Pingyin English name, Lingzhi Ganoderma lucidum seu Japonicum, Cangzhu Atractylodes lancea, Huangbo Phellodendron amurense
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo with Lingzhi(Granoderma Lucidum) and Sen Miao San Receives: Drug: Lingzhi and Sen Miao San |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: wk52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startMay 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Edmund K Li, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432484
- Sponsor's protocol ID
- RA-2005-001
- Status last verified
- May 2008
- First submitted
- 6 Feb 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17907228
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lingzhi (Ganoderma Lucidum) and Sen Miao San Supplementation in Rheumatoid Arthritis(RA): An Animal Model and A Phase I Study
- ClinicalTrials.gov ID
- NCT00432484
- Acronym / sponsor ID
- RA-2005-001
- Conditions
- Rheumatoid Arthritis
- Keywords
- Lingzhi, Sen Miao San, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 7 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Lingzhi and Sen Miao SanPlacebo with Lingzhi(Granoderma Lucidum) and Sen Miao San |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lingzhi and Sen Miao SanAlso: Pingyin English name, Lingzhi Ganoderma lucidum seu Japonicum, Cangzhu Atractylodes lancea, Huangbo Phellodendron amurenseG 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. | Drug | 1 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
- Derived from this study: PubMed 17907228Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmund K Li, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lingzhi and Sen Miao San in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.