SLE Clinical Trial
Official title:
Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-β1 (TGF-β1) Serum
Verified date | May 2017 |
Source | Saiful Anwar Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This a double blind randomised controlled trial (RCT) to determine the effect of Curcuma Xanthorrhiza supplementation on vitamin D3 administration to disease activity (SLEDAI), IL-6 and TGF-β1 serum in SLE patients with hypovitamin D. SLE patients with hypovitamin D had milder disease activity, lower IL-6 and higher TGF-β1 serum level when supplemented with Curcuma Xanthorrhiza and vitamin D3 compared with vitamin D3 and placebo.
Status | Completed |
Enrollment | 39 |
Est. completion date | March 13, 2017 |
Est. primary completion date | March 13, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - SLE based on the criteria of American Collage of Rheumatology (ACR) 1997 - Active SLE (SLEDAI> 3) - 25(OH)D level <30 ng/ml. Exclusion Criteria: - Pregnant - Taking supplements containing vitamin D and cur cumin - Had liver function disorders (SGOT/SGPT levels> 2.5 times the upper normal limit) - Had impaired renal function (GFR <25 ml/min) - Severe infections such as tuberculosis, pneumonia or HIV |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Saiful Anwar Hospital |
Handono K, Pratama MZ, Endharti AT, Kalim H. Treatment of low doses curcumin could modulate Th17/Treg balance specifically on CD4+ T cell cultures of systemic lupus erythematosus patients. Cent Eur J Immunol. 2015;40(4):461-9. doi: 10.5114/ceji.2015.56970. Epub 2016 Jan 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SLE disease activity | SLE disease activity was assessed using SLEDAI in the last 10 days | 3 months | |
Secondary | IL-6 | IL-6 serum level (pg/ml) | 3 months | |
Secondary | TGF-ß1 | TGF-ß1 serum level (pg/ml) | 3 months |
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