Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes

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

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-12-31

Brief Summary

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Traditionally, Black Seed (Nigella sativa) is a well-known food supplement and herbal product that has a wide range of medical claims (including asthma) that originate from different historical backgrounds. Today in the era of Evidence-based medicine, it is hard to accept those traditional medical claims of medicinal plants without valid scientific experiments. Thus, randomized clinical trials is important to rational the uses of herbal products.

Asthma is a common chronic disorder of the airways, characterized by variable reversible and recurring symptoms related to airflow obstruction, bronchial hyper-responsiveness, and underlying inflammation. In Saudi Arabia, Asthma is considered one of the leading chronic diseases affecting more than 2 million Saudi citizens. The global Asthma Report 2014 considered Asthma as an epidemic disease probably affecting about 334 million people worldwide and becoming a global health priority.

This project investigates the use of herbal products to enhance asthma control in Saudi Arabia. In this context, Black Seed is one of the common herbal products used traditionally for asthma in the Saudi region. Black seed is a common unconventional therapy used among 10% of Asthmatic patients in King Abdulaziz Medical city, Riyadh. In fact, there are some pre-clinical evidence and preliminary clinical studies support the usefulness of Black seed in Asthma and its underlying causes

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment

Black seed oil capsules

1g/day for 4 weeks

Group Type ACTIVE_COMPARATOR

Black seed oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (olive oil) capsules

1g/day for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

vegetable oil

Interventions

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Black seed oil

Intervention Type DIETARY_SUPPLEMENT

Placebo

vegetable oil

Intervention Type OTHER

Other Intervention Names

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Nigella sativa oil

Eligibility Criteria

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Inclusion Criteria

* Adult male/female (age 18-65 years),
* asthmatic patient with Asthma Control Test (ACT) score \<25
* No severe asthma exacerbation in the last 4 weeks
* Able to obtain consent

Exclusion Criteria

* Patients with serious co-morbid conditions such as; cancer, renal, hepatic, cardio-vascular, gastrointestinal diseases, mental health conditions and respiratory disorder such as TB and COPD.
* Smoking history
* Pregnant women
* Currently taking any form of Black seed.
* Known history of hypersensitivity to Black seed.
* Taking medications that may interact with black seed supplement: Anticoagulant/Antiplatelet, CNS depressants, and Immunosuppressant drugs

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No