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

Phase 2

Completed

• Conditions: Asthma
• Interventions: Other: Placebo; Dietary Supplement: Black seed oil

• Registration Number: NCT02407262
• Lead Sponsor: University College, London

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-02
• Study Start: 2015-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (olive oil) capsules 1g/day for 4 weeks
Treatment	Black seed oil	Black seed oil capsules 1g/day for 4 weeks

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Total IgE	4 weeks
Pulmonary function test (predicted FEV1%)	4 weeks
Serum inflammatory mediators	4 weeks	IL4, IL5, IL8, IL6, IL10, IL13, TNFa, IFN-g
Complete blood count (CBC)	4 weeks	Mainly blood eosinophils

Trial Locations

Locations (1)

King Abdulaziz University Hospital; 🇸🇦 Jeddah, Saudi Arabia