Effects of Nigella Sativa on T Cells and Cytokine Profile in Pediatric SLE Patients

August 18, 2024 updated by: Wisnu Barlianto, University of Brawijaya

Potential Effects of Nigella Sativa on T Lymphocytes and Inflammatory Cytokine Profile in Pediatric Systemic Lupus Erythematosus: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Malang, East Java, Indonesia, 65145
        • Universitas Brawijaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric SLE patients aging between 1 and 18 years old according to the 2010 ACR-EULAR criteria
  • Being under treatment with prednisone, hydroxychloroquine, and mycophenolic acid
  • Not receiving any biological agent or cytokine inhibitors for at least 2 months prior to the intervention

Exclusion Criteria:

  • Patients with any metabolic disorders (diabetes mellitus, Cushing's syndrome, and thyroid dysfunctions), any kidney or liver diseases, chronic inflammatory diseases (including inflammatory bowel diseases),
  • Patients with history of taking antioxidant or anti-inflammatory supplements 2 months prior to the interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSO group
NSO is 1 gram Nigella sativa oil in capsules. It was purchased from CV Rizki Abadi, Tuban East Java, Indonesia, with registration number POM TR. 183314171
Combination product: Standard Treatment for SLE
Standard Treatment for SLE
Placebo Comparator: Placebo group
Placebo capsules identical appearance contain 1 gram starch
Combination product: Standard Treatment for SLE
Standard Treatment for SLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T cell lymphocyte and cytokine profiles, as well as SLEDAI Score
Time Frame: up to 4 months

T cell lymphocyte includes Th1, Th2, Th17, and Treg in pg/mL (picograms per millilitre).

Cytokine profiles includes IFN-γ, TNF-α, IL-2, IL-4, IL-6, IL-10, and IL-17α in pg/mL (picograms per millilitre).

SLEDAI Score: SLE Disease Activity Index 2000 (SLEDAI-2K) in the point range between 0-105 (the higher the score the higher the disease activity). No activity (SLEDAI=0), mild activity (SLEDAI=1 to 5), moderate activity (SLEDAI=6 to 10), high activity (SLEDAI=11 to 19), and very high activity (SLEDAI≥20).

T-cell lymphocytes and cytokine profiles will be used to determine the immunomodulating effect of Nigella sativa oil on the change of disease activity through the SLEDAI Score of paediatric SLE patients.
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brawijaya

Investigators

  • Study Chair: Wisnu Barlianto, Dr. MD, Faculty of Medicine, Universitas Brawijaya
  • Study Director: Desy Wulandari, MD, Faculty of Medicine, Universitas Brawijaya
  • Principal Investigator: Tita L Sari, MD, Faculty of Medicine, Universitas Brawijaya
  • Principal Investigator: Rafika R Rachmaningrum, MD, Faculty of Medicine, Universitas Brawijaya
  • Principal Investigator: Rayi I Asasain, MD, Faculty of Medicine, Universitas Brawijaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Actual)

August 3, 2022

Study Completion (Actual)

January 3, 2023

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SLE NS CBA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SLE (Systemic Lupus)

Clinical Trials on Standard Treatment for SLE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe