Clinical trial · Interventional
Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SLE | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Cholecalciferol" and "C. Xanthorrhiza" | Dietary Supplement | — | UNRESOLVED |
| "Cholecalciferol" and "placebo" | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- "Cholecalciferol" and "C. Xanthorrhiza"
- description
- Subjects received Cholecalciferol 400 IU 3 times daily and C. Xanthorrhiza 20 mg 3 times daily per oral for 3 months (group II, n=19)
- interventionNames
- Dietary Supplement: "Cholecalciferol" and "C. Xanthorrhiza"
- type
- PLACEBO_COMPARATOR
- label
- "Cholecalciferol" and "placebo"
- description
- Subjects received cholecalciferol 3×400 IU and placebo 3×1 tablet for 3 months (group I, n=20).
- interventionNames
- Dietary Supplement: "Cholecalciferol" and "placebo"
Primary outcomes (1)
- measure
- SLE disease activity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDHandono 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. PMID 26862311
- DERIVEDSinggih Wahono C, Diah Setyorini C, Kalim H, Nurdiana N, Handono K. Effect of Curcuma xanthorrhiza Supplementation on Systemic Lupus Erythematosus Patients with Hypovitamin D Which Were Given Vitamin D3 towards Disease Activity (SLEDAI), IL-6, and TGF-beta1 Serum. Int J Rheumatol. 2017;2017:7687053. doi: 10.1155/2017/7687053. Epub 2017 Dec 28. PMID 29445400