A randomised, double-blinded clinical study of LC for systemic lupus erythematosus patients

ISRCTN	ISRCTN81818883
DOI	https://doi.org/10.1186/ISRCTN81818883
Secondary identifying numbers	DOH96-TD-I-111-006

Submission date: 18/01/2008
Registration date: 11/04/2008
Last edited: 11/01/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Heng-Hong Chang
Scientific

No.123, Dinghu Road
Guishan Shiang
Taoyuan
33375
Taiwan

Phone	+886 3 319 6200 ext. 2677
Email	tcmchh@adm.cgmh.org.tw

Study information

Study design	Double-blind randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet. Please note only available in Chinese.
Scientific title	Double-blind, randomised, placebo-controlled pilot study of LC in systemic lupus erythematosus
Study acronym	RDCSLS
Study objectives	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(s)	Institutional Review Board/Chang Gung Memorial Hospital (IRB/CGMH), 11/11/2007, ref: 96-1117C
Health condition(s) or problem(s) studied	Systemic lupus erythematosus (SLE)
Intervention	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
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Chinese formula LC
Primary outcome measure	1. Lupus disease activity, measured using SLEDAI-2K score at screening visit and on days 1, 112 and 168 2. Antioxidant function, measured using total antioxidant capacity, nitric oxide (NO), malondialdehyde (MDA), etc, 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, on days 1, 112 and 168
Secondary outcome measures	1. Quality of life, measured using the 36-item short-form health survey (SF-36) 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), 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
Overall study start date	01/11/2007
Completion date	31/10/2010

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	90
Key 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
Key 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
Date of first enrolment	01/11/2007
Date of final enrolment	31/10/2010

Locations

Countries of recruitment

Taiwan

Study participating centre

No.123, Dinghu Road

Taoyuan
33375
Taiwan

Sponsor information

Department of Health (Taiwan) - Executive Yuan
Government

No.100, Aiguo E. Road
Jhongjheng District
Taipei
10092
Taiwan

Website	http://www.doh.gov.tw/EN2006/index_EN.aspx
"ROR"	https://ror.org/0225asj53

Funders

Funder type

Government

Department of Health (Taiwan) - Executive Yuan

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	05/02/2016		Yes	No

Editorial Notes

11/01/2017: Publication reference added.