|
|
A Randomised, Double-blinded Clinical Study of LC for Systemic lupus erythematosus (SLE) patients
|
|
ISRCTN
|
ISRCTN81818883
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Randomised, Double-blinded Clinical Study of LC for Systemic lupus erythematosus (SLE) patients
|
|
Scientific title
|
Double-blind, randomised, placebo-controlled pilot study of LC in systemic lupus erythematosus
|
|
Acronym
|
RDCSLS
|
|
Serial number at source
|
DOH96-TD-I-111-006
|
|
Study hypothesis
|
LC, a mixture of two traditional Chinese herbal formulas, has been used for treatment of various disorders attributed to inflammation, including rheumatoid arthritis, herpes zoster, psoriasis, etc. Since immunopathological abnormalities usually occur in lupus mice and humans, we will evaluate the efficacy and safety of Chinese formula LC for the treatment of SLE patients.
Hypothesis:
Under conventional therapy, taking TCM formula LC would be beneficial to the quality of life (QOL) and/or disease activity of SLE patients better than patients receiving placebo.
|
|
Ethics approval
|
Ethics approval received from the Institutional Review Board/Chang Gung Memorial Hospital (IRB/CGMH) on the 11th November 2007 (ref: 96-1117C).
|
|
Study design
|
Double-blind, randomised, placebo-controlled trial
|
|
Countries of recruitment
|
Taiwan
|
|
Disease/condition/study domain
|
Systemic lupus erythematosus (SLE)
|
|
Participants - inclusion criteria
|
1. Patients fulfill the revised American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE)
2. Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score more than or equal to 2 and less than or equal to 36
3. Daily dose of prednisolone less than or equal to 0.6 mg/kg
4. Age more than or equal to 7 years old and body weight more than or equal to 40 kg, either sex
|
|
Participants - exclusion criteria
|
1. Alcoholism
2. Diabetes mellitus
3. Life-threatening disease
4. Pregnant or nursing women
5. Creatinine clearance less than or equal to 25 cc/min
6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than or equal to 2 x normal limit
|
|
Anticipated start date
|
01/11/2007
|
|
Anticipated end date
|
31/10/2010
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet. Please note only available in Chinese.
|
|
Target number of participants
|
90
|
|
Interventions
|
1. Intervention group: 3 g LC orally, after meal three times daily for 4 months then withdraw for 2 months to observe the effects
2. Control group: 3 g placebo orally with the same frequency and duration
|
|
Primary outcome measure(s)
|
1. Lupus disease activity, measured using SLEDAI-2K score, measured at screening visit and on days 1, 112 and 168
2. Antioxidant function, measured using total antioxidant capacity, nitric oxide (NO), malondialdehyde (MDA), etc., measured on days 1, 28, 56, 84 and 112
3. Immunological function, measured using antinuclear antibodies (ANA), anti-double strand deoxyribonucleic acid (DNA), anticardiolipin immunogobulin G (IgG), immunoglobulin M (IgM), erythrocyte sedimentation rate (ESR), etc., measured on days 1, 112 and 168
|
|
Secondary outcome measure(s)
|
1. Quality of life, measured using the 36-item short-form health survey (SF-36), measured on days 1, 112 and 168
2. Dosage of oral glucocorticoid, each prescription converted to daily measure of a prednisone-equivalent dose (in milligrams), measured at screening visit and on days 1, 28, 56, 84, 112 and 168
3. Cell markers, measured using cluster of differentiation 31 (CD31), CD34, CD45, CD133, vascular endothelial growth factor receptor 2 (VEGFR2), measured on days 1, 28, 56, 84 and 112
Safety evaluation:
1. LC medication record, measured on days 1, 28, 56, 84
2. Adverse event record, measured on days 28, 56, 84 and 112
3. Physical examination, measured on days 1, 28, 56, 84 and 112
4. Laboratory tests (complete blood count [CBC], creatinine [Cr], blood urea nitrogen [BUN], AST, ALT), measured at screening visit and on days 1, 28, 56, 84, 112 and 168
|
|
Sources of funding
|
Department of Health (Taiwan) - Executive Yuan
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Heng-Hong
Chang
|
|
Address
|
No.123, Dinghu Road
Guishan Shiang
|
|
City/town
|
Taoyuan
|
|
Zip/Postcode
|
33375
|
|
Country
|
Taiwan
|
|
Tel
|
+886 3 319 6200 ext. 2677
|
|
Fax
|
+886 3 329 4841
|
|
Email
|
tcmchh@adm.cgmh.org.tw
|
|
Sponsor
|
Department of Health (Taiwan) - Executive Yuan
|
|
Address
|
No.100, Aiguo E. Road
Jhongjheng District
|
|
City/town
|
Taipei
|
|
Zip/Postcode
|
10092
|
|
Country
|
Taiwan
|
|
Sponsor website:
|
http://www.doh.gov.tw/EN2006/index_EN.aspx
|
|
Date applied
|
18/01/2008
|
|
Last edited
|
11/04/2008
|
|
Date ISRCTN assigned
|
11/04/2008
|
|
|
