Condition category
Musculoskeletal Diseases
Date applied
18/01/2008
Date assigned
11/04/2008
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Heng-Hong Chang

ORCID ID

Contact details

No.123
Dinghu Road
Guishan Shiang
Taoyuan
33375
Taiwan
+886 3 319 6200 ext. 2677
tcmchh@adm.cgmh.org.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DOH96-TD-I-111-006

Study information

Scientific title

Double-blind, randomised, placebo-controlled pilot study of LC in systemic lupus erythematosus

Acronym

RDCSLS

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet. Please note only available in Chinese.

Condition

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

Phase

Not Specified

Drug names

Chinese formula LC

Primary outcome measures

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 measures

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

Overall trial start date

01/11/2007

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

90

Participant 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

Recruitment start date

01/11/2007

Recruitment end date

31/10/2010

Locations

Countries of recruitment

Taiwan

Trial participating centre

No.123, Dinghu Road
Taoyuan
33375
Taiwan

Sponsor information

Organisation

Department of Health (Taiwan) - Executive Yuan

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.tw/EN2006/index_EN.aspx

Funders

Funder type

Government

Funder name

Department of Health (Taiwan) - Executive Yuan

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes