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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2023-01-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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SLE (Systemic Lupus)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Standard Treatment for SLE

Intervention Type COMBINATION_PRODUCT

Standard Treatment for SLE

Placebo group

Placebo capsules identical appearance contain 1 gram starch

Group Type PLACEBO_COMPARATOR

Standard Treatment for SLE

Intervention Type COMBINATION_PRODUCT

Standard Treatment for SLE

Interventions

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Standard Treatment for SLE

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Wisnu Barlianto

Dr. dr. Wisnu Barlianto, Sp. A (K), Msi. med

Responsibility Role PRINCIPAL_INVESTIGATOR