Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560775
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Potential Effects of Nigella Sativa on T Lymphocytes and Inflammatory Cytokine Profile in Pediatric Systemic Lupus Erythematosus A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if Nigella sativa oil works to improve SLEDAI Score in SLE pediatric student It will also learn about the Treg T helper cells and cytokine of the patient The main questions it aims to answer are
Does Nigella sativa oil lower the SLEDAI Score in pediatric patient How does the effects of Nigella sativa oil on Treg cells T helper cells and cytokine in pediatric patient Researchers will compare Nigella sativa oil group to a placebo group a look-alike substance that contains no drug to see if Nigella sativa oil works to treat SLE in pediatric patients
Participants will
Visit the clinic once in the beginning for pre treatment checkups Take Nigella sativa oil or a placebo every day for 8 weeks Visit the clinic once every 4 weeks for checkups Visit the clinic after 8 weeks for post treatment checkups
Does Nigella sativa oil lower the SLEDAI Score in pediatric patient How does the effects of Nigella sativa oil on Treg cells T helper cells and cytokine in pediatric patient Researchers will compare Nigella sativa oil group to a placebo group a look-alike substance that contains no drug to see if Nigella sativa oil works to treat SLE in pediatric patients
Participants will
Visit the clinic once in the beginning for pre treatment checkups Take Nigella sativa oil or a placebo every day for 8 weeks Visit the clinic once every 4 weeks for checkups Visit the clinic after 8 weeks for post treatment checkups
Detailed Description:
SLE in paediatric patients requires long-term treatment with several side effects Nigella sativa is known to have immunomodulatory effects Our study aimed to investigate the immune-modulatory effects of Nigella sativa oil on T lymphocyte activity inflammatory cytokine profile and improvement of SLEDAI score in our patients This was a placebo-controlled clinical trial of Nigella sativa oil administration in 32 paediatric SLE patients who were tested before and after treatment The study subjects were randomly assigned Patients had blood samples taken to be tested for T cell ratio percentage of a number of cytokines IFN-γ TNF-α IL-2 IL-4 IL-6 IL-17 and IL-10 using flow cytometry and CBA Cytometric Bead Array and SLEDAI score at the beginning of the study and after treatment They were treated with 1 gram of N sativa oil capsules and 1 gram of placebo daily for 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None