NCT03140657

The Effects of Nanocurcumin on Treg Cells and Th17 Cells Responses in Ankylosing Spondylitis Patients

Completed Phase 2 Last updated 17 May 2019

What this trial tests

Phase 2 trial testing Nanocurcumin in Ankylosing Spondylitis in 24 participants. Completed in 18 January 2018.

Timeline

29 April 2017

Primary endpoint
7 November 2017

18 January 2018

Quick facts

Lead sponsor	Tabriz University of Medical Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	24
Start date	29 April 2017
Primary completion	7 November 2017
Estimated completion	18 January 2018
Sites	1 location across Iran

Drugs / interventions tested

• Nanocurcumin
• Placebo

Conditions studied

• Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →

Sponsor

Tabriz University of Medical Sciences

Who can join

Adults 23 to 46, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Ankylosing Spondylitis (AS) is a chronic rheumatic disease that principally affects the intervertebral and sacroiliac joints. Two major features of AS are inflammation and bone reformation. Th17 cells as a new subpopulation of CD4+ T cells, are characterized by the production of pro-inflammatory cytokines. Th17 cells have been implicated in autoimmune diseases, pathogenesis and diagnosis of several inflammatory diseases, such as AS. Regulatory T cells (Treg) with suppressive effects on inflammation and autoimmunity have been reported to implicate in pathology of AS. The Treg /Th17 functional balance is essential for the prevention of autoimmune and inflammatory diseases by preventing deleterious impairment to the host and mounting effective immune responses. A group of circulating miRNA in plasma is found to be the change they can be involved in inflammation or inhibit it. miRNAs have been shown to play a pivotal role in the pathogenesis of various diseases including autoimmune or auto-inflammatory diseases.The function and molecular pathways of several key deregulated miRNAs, are elucidated in AS patients. Curcumin is an active component of turmeric which is a perennial plant. Curcumin is able to exert anti-atherogenic, anti-cancer and anti-inflammatory effects. The curcumin induces down-regulation of various inflammatory cytokines including TNF-α and IL-1. The solubility of curcumin in nanomicelles spherical water increases to more than 100 thousand times, which significantly enhances the absorption of curcumin. The aim of the present study was to understand the nano-curcumin effects on frequency of Treg and Th17 cells, expression levels of their associated transcription factors and cytokines, secretion levels of their associated cytokines and also related miRNAs expression levels in peripheral blood of patients with AS and their correlation with the disease progression.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanocurcumin: A Promising Candidate for Therapeutic Applications.
   Karthikeyan A, Senthil N, Min T. · · 2020 · cited 200× · PMID 32425772 · DOI 10.3389/fphar.2020.00487
2. Nanotechnology's frontier in combatting infectious and inflammatory diseases: prevention and treatment.
   Huang Y, Guo X, Wu Y, Chen X, et al · · 2024 · cited 188× · PMID 38378653 · DOI 10.1038/s41392-024-01745-z
3. Foundations of gastrointestinal-based drug delivery and future developments.
   Chu JN, Traverso G. · · 2022 · cited 136× · PMID 34785786 · DOI 10.1038/s41575-021-00539-w
4. Stimuli-responsive nanocarriers for delivery of bone therapeutics - Barriers and progresses.
   Lavrador P, Gaspar VM, Mano JF. · · 2018 · cited 81× · PMID 29407678 · DOI 10.1016/j.jconrel.2018.01.021
5. Biomedical nanomaterials for immunological applications: ongoing research and clinical trials.
   Lenders V, Koutsoumpou X, Sargsian A, Manshian BB. · · 2020 · cited 59× · PMID 36132021 · DOI 10.1039/d0na00478b
6. Recent Advances in Nanotechnology with Nano-Phytochemicals: Molecular Mechanisms and Clinical Implications in Cancer Progression.
   Kim B, Park JE, Im E, Cho Y, et al · · 2021 · cited 28× · PMID 33808235 · DOI 10.3390/ijms22073571
7. Reconnoitering the Therapeutic Role of Curcumin in Disease Prevention and Treatment: Lessons Learnt and Future Directions.
   Sivani BM, Azzeh M, Patnaik R, Pantea Stoian A, et al · · 2022 · cited 26× · PMID 35888763 · DOI 10.3390/metabo12070639
8. Regulatory T Cells and Nanomaterials: Dual Perspectives in Therapeutics and Immunomodulation.
   Chen Y, Huang H, Wang X, Yu X, et al · · 2026 · PMID 41537174 · DOI 10.1002/smsc.202500481