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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81818883

Enrollment

Registered

2008-04-11

Start date

2007-11-01

Completion date

Unknown

Last updated

2017-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus (SLE) Musculoskeletal Diseases Systemic lupus erythematosus (SLE)

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 durat

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026