Effects of ?Black Seed? supplementation on management outcome of partially controlled asthma

Effects of Nigella sativa supplementation on airway resistance and inflammatory mediators in patients with partly controlled asthma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN48853858

Enrollment

120

Registered

2009-11-10

Start date

2009-10-01

Completion date

Unknown

Last updated

2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma (partly controlled) Respiratory Asthma

Interventions

1. Group 1 (n = 30) will be given a placebo and serve as the control group 2. Group 2 (n = 30) will be given 500 mg of Nigella sativa 3. Group 3 (n = 30) will be given 1 g Nigella sativa 4. Group 4 (

at the time of recruitment (baseline) and monthly thereafter for 3 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Established diagnosis of partly controlled asthma 2. Aged 18 - 60 years old, either sex 3. Willingness to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients whose compliance is less than 90% 2. Patients having chronic diseases (heart, liver or kidney disease, diabetes) 3. Patients on long-term oral steroids, leukotriene modifiers, anti-cholinergics, theophylline and cromones

Design outcomes

Primary

Measure	Time frame
The following assessments will be made during all the four visits to determine the effect of treatment with Nigella: 1. Anthropometric measurements including weight (measured using a digital Holtain electronic scale [150 ± 0.1 kg]) and height (measured with a Holtain stadiometer to the nearest millimetre). These measurements will be used for interpretation of lung function tests. 2. Clinical assessment, performed by pulmonologists in the research team at King Fahad Hospital of the University in Al-Khobar. It will be carried out according to the criteria adopted by the Global Initiative for Asthma (GINA 2008) to determine level of control of the patients. The asthma control test questionnaire will be filled for every patient. The type of medication used will also be recorded and any modifications needed will be noted and recorded. 3. Lung function tests: Peak expiratory flow (PEF), Forced Expiratory Volume in First second (FEV1) and forced vital capacity (FVC) will be measured during each visit for the sake of evaluating control. FEV1 and FVC will be measured using Vitalograph Pneumotrac® model 6800. Wright peak flow meter will be used for measurement of PEF. In addition, another independent indicator of asthma control; variability in airflow limitation will be evaluated. For this sake a hand held portable Peak Expiratory Flow meter will be given to every patient in the study. The patients will be asked to measure their PEF twice every day. This will be preceded by careful explanation of the procedure to the patients. These measurements will be performed during the week preceding the start of the trial to establish baseline data and will be repeated during the week preceding every visit. The patients will be reminded in due time. PEF is measured first thing in the morning before treatment is taken, when values are often close to their lowest and last thing at night. PEF variability will be evaluated by obtaining the difference between the maximum and minimum over t	—

Measure

Time frame

The following assessments will be made during all the four visits to determine the effect of treatment with Nigella: 1. Anthropometric measurements including weight (measured using a digital Holtain electronic scale [150 ± 0.1 kg]) and height (measured with a Holtain stadiometer to the nearest millimetre). These measurements will be used for interpretation of lung function tests. 2. Clinical assessment, performed by pulmonologists in the research team at King Fahad Hospital of the University in Al-Khobar. It will be carried out according to the criteria adopted by the Global Initiative for Asthma (GINA 2008) to determine level of control of the patients. The asthma control test questionnaire will be filled for every patient. The type of medication used will also be recorded and any modifications needed will be noted and recorded. 3. Lung function tests: Peak expiratory flow (PEF), Forced Expiratory Volume in First second (FEV1) and forced vital capacity (FVC) will be measured during each visit for the sake of evaluating control. FEV1 and FVC will be measured using Vitalograph Pneumotrac® model 6800. Wright peak flow meter will be used for measurement of PEF. In addition, another independent indicator of asthma control; variability in airflow limitation will be evaluated. For this sake a hand held portable Peak Expiratory Flow meter will be given to every patient in the study. The patients will be asked to measure their PEF twice every day. This will be preceded by careful explanation of the procedure to the patients. These measurements will be performed during the week preceding the start of the trial to establish baseline data and will be repeated during the week preceding every visit. The patients will be reminded in due time. PEF is measured first thing in the morning before treatment is taken, when values are often close to their lowest and last thing at night. PEF variability will be evaluated by obtaining the difference between the maximum and minimum over t

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026